CN101795630B - Atherectomy devices, systems, and methods - Google Patents

Abstract

The devices and methods generally relate to treatment of occluded body lumens. In particular, the present devices and method relate to removal of the occluding material from the blood vessels as well as other body lumens.

Description

Atherectomy devices, system and method

Related application

The application requires the rights and interests of No. the 61/013998th, the U.S. Provisional Patent Application sequence submitted on April 10th, 2008 and be entitled as " AtherectomyDevices and Methods (rotary-cut art (speckle rotary-cut art) apparatus and method) ", and it is incorporated into this for your guidance.

The application also requires the rights and interests of No. the 60/981735th, the U.S. Provisional Patent Application sequence submitted on October 22nd, 2007 and be entitled as " AtherectomyDevices and Methods (Atherectomy devices and method) ", and it is incorporated into this for your guidance.

The application or on June 29th, 2007 U.S. Patent application sequence the 11/771st that submit to and that be entitled as the common pending trial of " AtherectomyDevices and Methods (Atherectomy devices and method) ", No. 865 part continuation application, this U.S. Patent application sequence the 11/771st, No. 865 is December in 2006 U.S. Patent application sequence the 11/567th that submit to and that be entitled as the common pending trial of " AtherectomyDevices and Methods (Atherectomy devices and method) " on the 6th, No. 715 part continuation application, this U.S. Patent application sequence the 11/567th, No. 715 is U.S. Patent application sequence the 11/551st that submit to and that be entitled as the common pending trial of " AtherectomyDevices and Methods (Atherectomy devices and method) " on October 19th, 2006, No. 191 continuation application, this U.S. Patent application sequence the 11/551st, require U.S. Provisional Patent Application sequence the 60/806th that submit to and that be entitled as " AtherectomyDevice (Atherectomy devices) " on June 30th, 2006 for No. 191, No. 417 rights and interests, it also requires U.S. Provisional Patent Application sequence the 60/820th that submit to and that be entitled as " Atherectomy Device (Atherectomy devices) " on July 26th, 2006, No. 475 rights and interests all are incorporated into this for your guidance with it.

Technical field

Be usually directed to treat device, the system and method for occluding body lumens (occluded body lumen), for example, be used for removing clogged material from blood vessel and other body part.

Background technology

I. peripheral arterial disease

Peripheral arterial disease (PAD) is a kind of progressive disease (progressive disease).In this disease, form tremulous pulse by gathering the speckle and the neointimal hyperplasia that cause blood flow to block.Speckle (gathering of cholesterol, cell and other fatty material) is normally frangible, and may naturally move or move in the endovascular treatment process, may cause the thromboembolism of downstream blood vessel.

According to estimates, promising 30,%12,000,000 people of the U.S. suffer from PAD, if do not treat, and 30% mortality rate in 5 years.The annual case that about 160,000 amputation are arranged owing to serious limb ischemia (suffer from the patient of PAD in the middle of the most serious classification).The popular of PAD rises, and its risk factor comprises age, obesity and diabetes.

Reduce or remove and block to recover chamber diameter (luminal diameter) and allow blood flow increased to that clear program is known in the blood vessel of normal level.The removal speckle has the effect of removing illing tissue and helps to eliminate a disease.Keep a period of time (several thoughtful many weeks) can allow blood vessel is transformed into more normal state from previous pathological state the chamber diameter.Another purpose of clear program is to prevent short-term complication (for example, the thromboembolism of blood vessel wall or perforation) and long-term complications (for example, thrombosis or restenosis cause ischemia) in the blood vessel.

II. the form of therapy (pattern) before

Different from coronary heart disease, the treatment that is used at present PAD (PAD that comprises the lower limb tremulous pulse) is selected owing to following three main causes have significant limitation at least: A) speckle of larger volume gathers in very long dispersivity pathological tissues, B) low blood flow promotes thrombosis and speckle to gather, and C) the lower limb tremulous pulse is crooked in the process of routine motion, distortion, stretch and shrink.

Attempt various form of therapy and realized therapeutic goal.In speckle rotary-cut art (medicated porridge sample speckle excision), cut away or excise speckle.Used various structures, comprised the rotating cylindrical razor or the groove cutter is arranged.For safety, device can comprise for example some protection forms of housing.Device can comprise the removal of fragment, for example by fragment in the capture catheter, in the downstream filter or suck fragment.In some cases, can use grinding core (burr) to replace cutter, especially the pathological tissues of severe calcification be worn into very little granular size.Suction also can be used with grinding core type speckle Atherectomy devices.

The existing example of speckle Atherectomy devices is Fox Hollow Technologies

Speckle excision system.SilverHawk has significant limitation and (comprises; the time span of cavity (lumen) is removed in treatment); it needs the conduit of a plurality of devices and repetition to change; it produces embolic debris; and it uses the easily Tool Design of impaired (lacking protection); this design needs patient and careful greatly, to get through cavity when not injuring blood vessel wall.In use, the doctor makes conduit pass pathological tissues and moves forward, shave off the speckle of arterial wall and collection speckle in the long container (nose cone body) at the place, tip of conduit (must in blood vessel, have enough spaces pivoting, thereby near cutting blade).When container fills up, must remove conduit, empty container, and repetitive routine is until remove enough specklees to recover normal blood flow.This program can comprise, replaces described conduit with the conduit of larger diameter, to enlarge the size of removing.It mainly is straight cavity that the use that the long container at catheter tip place will install is limited to.

Balloon angioplasty (balloon angioplasty) is the endovascular treatment program of another kind of type.Balloon angioplasty enlarges and opens tremulous pulse by shifting speckle and compressing it, compresses by the air bag that enlarges in the tremulous pulse, has some variations that comprise the air bag that is coated with medicine.Known balloon angioplasty can produce barotrauma (windage) to blood vessel from the required high pressure of compression speckle, and can cause the incision of blood vessel wall.This wound causes unacceptable high restenosis rate.In addition, this program may be inefficent for the treatment of elastic type plaque, and wherein, but thereby cavity is blocked in such tissue resilience.

Low temperature angioplasty (cryoplasty) has only occurred several years, and limited good effect only is provided.In the situation that the low temperature angioplasty, the restenosis that main problem seemingly prolongs the cycle after (for example, a year).Except not keeping blood vessel opens with support, the balloon angioplasty program of using in this technology and the cardiovascular is similar.In the situation that the low temperature angioplasty flashes to gas and air bag is cooled to approximately-10 degrees centigrade (14 degrees Fahrenheits) by the liquid nitrous oxide that will enter air bag.When it cooled off, the plaque rupture of obstructing arterial allowed the expansion ratio of blood vessel to occur in more even in the standard angioplasty program.

Developed various forms of laser speckle rotary-cut arts, and it has mixing resultant.One of laser system main limitation is, laser only can be effectively used in the straight cavity, and in crooked cavity or the effect around it be lower.When laser is in suitable position, the fluctuating light beam of its emission evaporation speckle.Laser system is because laser characteristics and lower for the effect of removing calcification group.

Erection bracket (stenting) also can be used as a kind of selection for the treatment of.Independently, support (comprising bracket for eluting medicament) can not show in peripheral vasculature (peripheralvasculature) well owing to a variety of causes.Often performance is bad in the mechanical environment of the harshness of peripheral vasculature with the support that enough radial forces are provided reopen tremulous pulse to have essential structural intergrity.For example, run into quite a large amount of compressions, reverse, extend and crooked when peripheral vasculature.Such environment can cause stent failure (pillar breaks, support fragmentation etc.), and it finally threatens support to keep for a long time the ability of cavity diameter.Erection bracket also is vulnerable to the restenosis in the support, typically occurs 30% or higher restenosis rate.Support breaks or restenosis may need follow-up blood vessel bypass art, and it is invasive and is limited to the type that pathological tissues maybe may produce the obstruction of artery that can accept the result.Do not advise erection bracket in will selecting as the zone of the near-end in the operation bypass procedure process or far-end anastomosis (anastamosis), because the support in should the zone makes bypass difficult or impossible.

The support that on the other hand, can bear the harsh mechanical aspects of peripheral vasculature will not provide enough radial forces of getting through satisfactorily blood vessel usually.In many cases, practitioner expectation ability that clear program in the blood vessel is combined with erection bracket.Such erection bracket can appear in the blood vessel before the clear program, afterwards, or before and afterwards.

Therefore, existence is for the device of the improved speckle rotary-cut art of permission system, the needs of system and method, described rotary-cut art system can dissect in bending (tortuous anatomy) process and handles, and from body cavity (for example, blood vessel) removes material, at the body cavity place, system comprises that permission shaves off or grind the feature of endoceliac material with safety, effective and controlled mode when (procedure times) minimizes with treatment time.In addition, the needs that have the system that turns to for the distal portions that allows to make system when in bending dissection process, handling.Steering capability helps the doctor to carry out the bending dissection, and can further help seal wire is delivered in the entrance of angled or crooked vascular bifurcation place/section (sections).This is possible, because described hereinly turn to the modification of rotary-cut art conduit system also to can be used as " reciprocating type conduit (shuttle catheter) ", wherein, the doctor can aim at far-end blood vessel to be approached, and makes seal wire intravasation in the conduit.

But also there are the needs that when not being hinged, will keep the device of straight structure to being configured to turn to.Usually known, have the conventional catheters of definite shape usually by repeating hinged or even after any given time cycle of packing, being biased into a side.Therefore, when the combination of such erection bracket feature and tissue ablation system (tissue debulking systems), if when the tissue ablation system that originally is designed to straight structure occur not expecting crooked the time, then can have the danger of damage.

Device for excising described herein, system and method have solved problem above-mentioned, and significantly improved feature is provided, and dissect to turn to device for excising to allow the doctor by bending, and remove the tissue of target location.

Summary of the invention

Device described herein, system and method provide and had improvement (device (means)) to remove the device for excising (debulkingdevices) of the obstruction in the body cavity (especially vascular system), comprise for thrombectomy and/or be used for speckle rotary-cut art.In many modification, this device is suitable for operating by curved blood vessel.The feature of apparatus and method allow clogged material controlled removal and by (navigation through) crooked with ill blood vessel.In some modification, the method and device also have in the situation that need not device from body cavity removal, the feature that can material be transported from operating position.Other aspect comprises that controllable rate that tissue is removed and other prevent the security feature of unexpected cutting chamber wall.Although apparatus and method described herein have been discussed from blood vessel and have been removed material,, in some cases, these apparatus and method also can be applicable to other body part.Should be noted that, the modification of device described below and feature can optionally be comprised, perhaps with the combination of basic device construction, this structure comprises the flexible body with cutter, wherein, cutter comprises housing and cutter (cutter), and wherein, housing and cutter can relative to each other rotate.Modification is included in the cutter of rotation in the housing, the housing that centers on the cutter rotation and their combination.

In one aspect of the invention, device, system and method are provided for excising the system and method for material.This system can be included in the distal portion office of conduit or have the conduit of cutting tissue assembly (tissue removal assembly) near it, and the cutting tissue assembly has a diameter.Deflection piece can be suitable for manipulation of tissue excision assembly and (melt, debulk) tissue in the blood vessel with excision.The cutting tissue assembly can be suitable for producing the diameter of organizing of removing in vascular, and this diameter is at least twice of the diameter of cutting tissue assembly.

Can set size and texture excision assembly, comprise the tissue of acute thrombus, organized thrombus, atheroma, fibrous plaque and calcified plaque with removal.Being used for the vascular that tissue removes can include, but are not limited to: brachial artery, common iliac artery, external iliac artery, internal iliac artery, femoral artery, deep femoral artery, dark femoral artery, near-end femoral artery,superficial (nearly surperficial femoral artery), the interior tremulous pulse, of Hunters canal (adductor canal) popliteal tremulous pulse, posterior tibial artery, anterior tibial artery, peroneal artery, dorsal artery of foot, medial plantar and outside tremulous pulse and refer to tremulous pulse.

In another aspect of this invention, device, system and method provide the system and method that is used for the excision material.This system and method can be included in the distal portion office of conduit or have the conduit of deflection section near it, and this deflection section has length L, straight axis S and clinoid D.Deflection piece can be connected to conduit, and is suitable for operating the deflection section of conduit, so that the length L of deflection section is deflected to clinoid D from straight axis S, to produce angle A between straight axis S and clinoid D, the scope of angle is between 0 degree is spent to 90.

In various embodiments of the present invention, set size and structure conduit to use 8Fr or less conductor to be incorporated in the blood vessel.Also the size of conduit and structure are set for and when staying in 8Fr or the less conductor, allowed injection of contrast agent (contrast).

In still another aspect of the invention, device, system and method provide the system and method that is used for control excision material.This system and method can comprise the control handle (control handle) that is connected to conduit, and control handle comprises deflection control device and rotating control assembly.Deflection control device can be on the radial deflection direction from the distal portions of the axis tilt conduit of conduit, and rotating control assembly can be suitable in the distal portions of deflectable catheter the distal portions of rotary guide pipe on curved path.

In a modification, deflection control device and rotating control assembly comprise deflection and Spin Control handle (control handle, control knob), its be suitable for the distal portions of deflectable catheter and in the distal portions of deflectable catheter on curved path the distal portions of rotary guide pipe.

In another modification, deflection and Spin Control handle are suitable for by deflection and Spin Control handle are applied the first power and the distal portions of deflectable catheter, and, deflection and Spin Control handle be suitable in the distal portions of deflectable catheter by deflection and Spin Control handle are applied the second power and on curved path the distal portions of rotary guide pipe.

Of the present invention other aspect in, device, system and method provide the system and method that is used for control excision material.This system and method can comprise the conduit tube component that is dimensioned and is configured to be incorporated in the blood vessel, this conduit tube component comprises near the far-end of conduit tube component or its organizes cutting assembly (tissue cutting assembly), organizes cutting assembly to comprise for the rotatable tool from the vessel resection tissue.Control handle can be connected to conduit tube component, control handle comprise be used to make the transfer of organizing cutting assembly to turn to, be used for the rotation rotatable tool rotary apparatus, be used to rotary apparatus that the power set (power means) of power are provided, rotary apparatus is suitable for rotating rotatable tool, and is used for the opening/closing device that control is supplied to the power of rotary apparatus.Torsional axis can extend to rotatable tool from rotary apparatus, and torsional axis comprises aspirator (suction apparatus, aspiration means), moves to container will cut and organize by conduit tube component and at least a portion by control handle from rotatable tool.

Of the present invention other aspect in, device, system and method provide the system and method that is used for control excision material.This system and method can comprise the conduit tube component that is dimensioned and is configured to be incorporated in the blood vessel, this conduit tube component comprises the cavity that runs through wherein and at the far-end of conduit tube component or organize cutting assembly near it, the cutting tissue assembly comprises for the rotatable tool (rotatable cutter) from the vessel resection tissue.Control handle can be connected to conduit tube component, and control handle comprises be used to the transfer that the cutting tissue assembly is turned to (steeringmeans).In addition, curved frames can be connected to transfer, curved frames is included on the first radial side of curved frames at least has the post intensity (breaking strength that reduces, columnstrength) part, curved frames are suitable for after the first power is applied to transfer the direction upper deflecting in the first radial side and organize cutting assembly.

In one aspect, curved frames can be configured to limit the deflection of cutting tissue assembly.Curved frames also can be connected to conduit tube component.In various structures, be suitable for conduit tube component and the sizing of thrombectomy and/or speckle rotary-cut art and be configured to use 8Fr or less conductor to be incorporated in the blood vessel, and conduit tube component can be suitable for being no more than once being introduced in the blood vessel.

In another aspect of this invention, device, system and method provide the system and method that is used for control excision material.This system and method can comprise the conduit tube component that is dimensioned and is constructed to be incorporated in the blood vessel, this conduit tube component comprises the cavity that runs through wherein and at the far-end of this conduit tube component or organize cutting assembly near it, this tissue cutting assembly comprises for the rotatable tool from the vessel resection tissue.Control handle can be connected to conduit tube component, and control handle comprises the transfer of organizing cutting assembly to turn to be used to making.

In one embodiment, the first tumbler can be positioned at inside or the outside of catheter lumen (catheter lumen), and the first tumbler is suitable for organizing cutting assembly in the situation that the first power is applied to the first tumbler deflection.The second tumbler also can be connected to transfer, and the second tumbler is suitable for the first power and the second power transmission (transfer) to the first tumbler.In this structure, the deflection that the first power is suitable for causing the first tumbler and organizes cutting assembly, and the second power is suitable for causing the first tumbler and organize the rotation of cutting assembly on curved path.

A modification of device described herein comprises the device that is configured to remove from body structure material.This device can be vascular device (vascular device), and has guiding (navigate) and carry out crooked desired structure and structure of dissecting.Replacedly, this device can be the cutter that has the feature of expectation when other parts of being used to dissect.

Under any circumstance, the modification of this device comprises catheter body (catheter body), and this catheter body has near-end and far-end and runs through wherein catheter lumen; Cutting assembly, this cutting assembly comprises housing and is positioned at the rotatable tool of housing, cutting assembly is fixed to the far-end of conduit, wherein, housing comprises that at least one opening and cutter comprise at least one cut edge (blade), scanning framework (sweep frame) is positioned near the cutting assembly, scan framework and be connected to conduit and can rotating independently with rotatable tool, wherein, scan framework and on the first radial side, comprise at least weakening part (weakened section), cause towards the first radial side deflection so that scan the compression of framework, the result causes the deflection at the far-end of catheter body, and wherein, the rotation of scanning framework of deflection is moved cutting assembly with respect to the near-end axis that scans framework on curved path; And rotatable torsional axis, this rotatable torsional axis extends through catheter lumen and scans framework, and has the first end that is connected to rotatable tool and the second end that is suitable for being connected to rotating mechanism.

Point out as following, scan framework and can have any amount of structure.Yet, scan the irrelevant rotation of distal portions that framework should allow the bending of distal portions of conduit and conduit and torsional axis and rotatable tool.In some modification, scan framework and be independent of the catheter body rotation, and in other modification, scan framework and rotate with catheter body.In other modification, the far-end of catheter body rotates with scanning framework, and simultaneously, it is static that the proximal part of catheter body keeps.In addition, device of the present invention can have the framework that scans at any amount of length place that approximately is positioned at catheter body, and wherein, each scans the bending that framework allows the relevant section of conduit.It is flexible that these scan framework, and can rotate independently of one another.Replacedly, if desired, the crooked or rotation of scanning framework can couple together.

System of the present invention can further comprise the handle that is connected to near-end, wherein, scans framework and can be independent of handle and rotate.Typically, activate and scan framework by scanning part (sweep member) or scanning axle (sweep shaft).Axle is scanned in manufacturing, is transferred to and scans framework from handle or the near-end of device so that it can and rotatablely move axial force.

In some modification, scan framework be configured to the deflection limitation of cutting assembly for maximum deflection angle from the proximal shaft preset distance that scans framework.In other modification, bending rigidity and the potential juxtaposition power (apposition force) that causes can change along with the deflection angle of cutting assembly or displacement, and change along the axial location that scans framework.

In other modification, the weakening part that scans framework comprises the post intensity of variation (column strength), and it increases in the circumferential direction away from the first radial side, with the radial distorted that prevents from scanning framework when the deflection.Such structure be intended to when crooked, to prevent to scan framework weakening part distortion or reverse.In a modification, scan framework and comprise that the such priority bending towards the first radial side of realization also increases the pillar (struts) away from the post intensity of the first radial side.

In most of modification, scan framework and all be positioned at catheter body.Yet, in other modification, scan that framework can be exposed or on the outside of conduit.In any situation, scan framework and be connected to conduit, with the bending that allows conduit with turn to.

Described herein scan frame structure can with the cutting assembly combination same description of any number or known to those skilled in the art.

For example, in a modification, cutter can comprise and a plurality ofly is positioned at nearly groove (nearly groove nearfluted) has a groove cut edge (fluted cuttingedges) on cutting part and the groove cutting part far away, wherein, nearly groove cutting part and groove cutting part far away separate along tool axis, and, groove cutting part far away the groove cut edge is arranged than the lacking of nearly groove cutting part, wherein, when cutter rotates, there is the groove cut edge to remove material from body cavity.

Cutting assembly can comprise the cutting housing that has a plurality of openings along the outer surface of housing.Replacedly, housing can be the cylindrical housings with open front (front).The face-piece body (open faced housing) of opening like this can anyly rotate (rotate together with rotatable tool or rotate in relative direction), and in this case, housing is as cutter.Replacedly, open the face-piece body and can keep static.

In the other modification of device, cutting assembly can comprise from the anterior expander component (dilator member) of extending of housing terminally, this expander component has the passage that runs through wherein and is communicated with the catheter lumen fluid, wherein, expander component comprises conical by its shape, its endways (far-end) have less diameter surface, and has larger diameter surface near the anterior place of housing, thereby, when expander component is advanced when passing material, this expander component distention substance makes it enter opening in the housing.

The present invention also comprises for the method for removing the clogged material in the body.Such method can comprise and move forward the have elongate articles conduit of (slender member), and described elongate articles is with the excision assembly of the far-end that is fixed to elongate articles in body cavity; The excision assembly is positioned near the clogged material place in the body cavity, the excision assembly has cutter and is connected to the distal portions of conduit and the curved frames of close excision assembly, wherein, curved frames is included in the part that has the post intensity that reduces on the first radial side of curved frames at least; Move forward by the near-end at conduit and to scan part and at the direction upper deflecting curved frames of the first radial side, wherein, the deflection curved frames makes the excision assembly also at the direction upper deflecting of the first radial side; Rotation torsional axis, torsional axis run through conduit and are connected at least cutter to remove clogged material; And rotate independently with torsional axis and to scan part, with the rotoflector framework and excision assembly near-end axis with respect to curved frames on curved path is scanned.

As discussed here, the modification of new device comprises one or morely scans framework and/or scans pipe (sweep tubes), with the deflection of the distal portions (and other parts) that causes removal device (debulking device).Scan framework and improved prior device, because it makes conduit keep straight when being in straight position.In other words, when device specifies is in straight position, scans framework and prevent from removing " bending " that the conduit generation is not expected.Like this predefined curved (the set bends) that do not expect is general in traditional turned to conduit.The predefined curved removal device that reduced of avoiding not expecting produces the probability of undesired indirect injury (collateral damage) to health tissues.For example, the prior device of (after bending repeatedly, or because the time expand in the packing, or because being exposed to high temperature) of when the doctor supposes that this device is straight, bending may rely on the health tissues entirely.Significantly, the activation of prior device in such environment can stop the doctor that removal is limited to destination organization.

Except being easy to structure (for example, simple and cheap structure) in addition, scan framework fabulous post intensity also is provided, to improve the forward direction cutting speed in straight and position deflection.Find that this structure can prevent the failure mode that shell ruptures thereon, and, be spirally wound on around the torsional axis.In addition, scan framework fabulous juxtaposition power is provided, to cut better the diameter larger than the diameter of conduit.

In addition, provide must be compressed scanning framework and can allow optionally " adjustment " structure with deflection, so that when the sweep that scans framework arrived the greatest hope deflection of expectation, the section that forms sweep was mechanically interfered, to prevent further bending.

In another modification, the scanning framework and can comprise feature of this device is so that the doctor can be from without the bending direction of invading imaging device and determine device.For example, scan framework or with scan the conduit that framework is connected and can comprise one or more visual indicias, it allows to scan the orientation of connection (link) and the determining without invading of direction of framework.The shape that can make visual indicia with as the plane of bending of radiation labelling (cutout or projection) is not asymmetric thoroughly, so that the direction that enters device tip out, fluoroscopy plane/from the fluoroscopy plane when the deflection to be shown.Labelling also can be increase by saturating striped/belt of making of radiative material (for example, tantalum, gold, platinum etc.)/electric wire etc.

In the other modification of method or device, can scan part with respect to the device locking, further crooked or not crooked to prevent curved frames.It also can with respect to independently locking of device, scan preventing.

Apparatus and method also comprise by fluid port transmission fluid.Fluid can comprise medicine or other material of auxiliary treatment program (procedure).

Another modification of the method for the tissue within being used for the removal body passage, the method can comprise moving forward to have the conduit that excises assembly, and the excision assembly is fixed to the far-end of the conduit in the health; The excision assembly is positioned near the tissue place in the health; Near-end at conduit applies distal force, with the curved frames deflection of the distal portions that will be connected to conduit; Rotoflector framework in the deflection curved frames scans the excision assembly with the near-end axis with respect to curved frames at curved path; Rotation torsional axis, torsional axis run through conduit and are connected at least cutter to remove tissue; And rotate independently with torsional axis and to scan part, with the rotoflector framework and cause excising assembly near-end axis with respect to curved frames on curved path and scan.

Another modification of this method is that the deflection far-end also advances conduit, with in the axial direction cutting.Can repeat the axis cutting pattern in follow-up radial position place, to remove tissue.

Another modification of the present invention is to locate also deflection the second bending or scan framework along catheter body, to move forward the excision assembly by the first direction of scanning the framework setting, to increase the scope (extension) of excision assembly.Second scans framework can provide counteracting force for the juxtaposition power near the cutter of speckle or tissue, and does not need to come from the counteracting force with the interactional catheter body of blood vessel wall.The second curved frames also can be used to allow cutting-tool angle with respect to the accurate control of tissue to be excised.Rotatable second scans axle to scan the excision assembly.

As discussed here, some modification of device have hinged ability.This hinged permission is diverted to the target location with device, and produces the motion of scanning of tissue removal.When attempting at bending dissection guiding seal wire, this steering capability is useful.For example, when the bending dissection moved forward seal wire, the doctor met obstructions usually, or because endovascular obstruction or because the crooked character of vascular system.When the doctor runs into such resistance, can in ablation catheter, regain seal wire or extend a little from ablation catheter.Then, the doctor can make ablation catheter turn to, and to change the direction of seal wire, it is advanced.In case seal wire is in suitable position, then the doctor can start cutting mechanism, optionally to remove tissue.

Device described herein can have toolbox, and the part of its housing has curved surface, and herein, and opening strides across curved surface and forms the plane so that when cutting surfaces when opening rotates, the part of cutting surfaces is stretched out from housing by opening.Toolbox also can have various further features as described below, and it is owing to the hinged safety that improves device in cutting.In addition, cutter can have a large amount of promotions or driving and cuts and organizes and enter the feature of toolbox finally to be removed by one or more transmission parts (conveying members).

As noted, device described herein can have one or more transmission parts, and it transmits material and/or fluid by device.Such feature can be used to cut and organize and fragment from the treatment position removal in therapeutic process.In some modification, device can comprise a plurality of conveyer belts that transport fluid and remove fragment (conveyors).Yet device of the present invention also can have for catching fragment that therapeutic process produces or the container of other material.

Here, the another feature for the present invention is the use of the grinding core (grinding burr) that is rotatably connected with the device tip.Grinding core can be used to remove the otherwise tissue of not easy-to-use toolbox cutting.

Device described herein can advance by health with seal wire.Under these circumstances, device will have the guidewire lumen that is positioned at around conduit or its.Replacedly, the seal wire part can be fixed to the part of device.

Device of the present invention typically comprises the torsional axis that is sent to the parts in the toolbox with rotatablely moving.Torsional axis can comprise one or more cavitys.Replacedly, torsional axis can be solid member or hollow element.The modification of torsional axis also comprises those known aspects in the conduit type devices (for example, the coil of reverse-winding, consolidate member etc.).In some modification, torsional axis can have around the outer surface of axle or the integrally formed transmission parts of inner surface.Replacedly, or in combination, transmission parts can be positioned at such as (or being positioned at its inside) on the torsional axis described herein.

Instruction (instructions) can be provided with system described herein, but and various programs and the use of descriptive system.For example, the instruction of using can be described the use of conduit, instruction comprises following operation: near the position that conduit tube component is incorporated in the blood vessel and will organizes cutting assembly to be positioned to need cutting tissue or its, manipulation of tissue is removed assembly with the tissue in the excision blood vessel, in vascular, produce the diameter of organizing of removing, this diameter is removed at least twice of the diameter of assembly for tissue, and removes the tissue of removing.

Instruction or method that be used for to describe the use of conduit also can comprise following operation: conduit tube component is incorporated into blood vessel and will organizes cutting assembly to be positioned near the position that needs cutting tissue or its, thereby the distal portions of operational deflection control device deflectable catheter, thereby and the distal portions of operation rotating control assembly rotary guide pipe on curved path.

Other method or instruction that be used for to describe the conduit operation can comprise, be incorporated into conduit tube component in the blood vessel and the position that will organize cutting assembly to be positioned to need cutting tissue or its near; Scan part and at the direction upper deflecting curved frames of the first radial side of curved frames by mobile in the proximal end of conduit or near it, thereby cause organizing cutting assembly at the direction upper deflecting of the first radial side; Rotation runs through conduit and is connected at least the torsional axis of rotatable tool; Scan part with the rotoflector framework and cause organizing cutting assembly to scan at curved path with respect to the near-end axis of curved frames with torsional axis is mobile independently; And removal clogged material.

The other method or the instruction that are used for the operation of description conduit can comprise, the conduit that is dimensioned and is configured to be incorporated in the blood vessel is provided, conduit comprises near the far-end of conduit or its organizes cutting assembly, organizes cutting assembly to comprise for the rotatable tool from the vessel resection tissue; The control handle that is connected with conduit tube component is provided, and control handle comprises the transfer of organizing cutting assembly to turn to be used to making; Conduit is incorporated in the iliac artery; Make conduit enter tremulous pulse, popliteal tremulous pulse, tibial artery, peroneal artery, dorsal artery of foot, medial plantar artery, lateral plantar artery in femoral artery, deep femoral artery, the Hunters canal, or the finger tremulous pulse; To organize cutting assembly to be positioned at tremulous pulse, popliteal tremulous pulse, tibial artery, peroneal artery, dorsal artery of foot, medial plantar artery, lateral plantar artery in the femoral artery, deep femoral artery, Hunters canal, or near the target location in the finger tremulous pulse or its; Operate transfer by the first power is applied to transfer, the first power causes the distal portions of conduit at the radial direction upper deflecting; Operate transfer by the second power is applied to transfer, the second power causes the distal portions of conduit to rotate at curved path in the radial direction upper deflecting at distal portions; Make the conduit terminad advance to scan the target location, thus allow rotatable tool on curved path from target location resection organization; And remove the tissue excise from the target location, thereby process blood vessel.

The other method or the instruction that are used for the operation of description conduit can comprise, the conduit that is dimensioned and is configured to be incorporated in the blood vessel is provided, conduit comprises near the far-end of conduit or its organizes cutting assembly, organizes cutting assembly to comprise for the rotatable tool from the vessel resection tissue; The control handle that is connected with conduit tube component is provided, and control handle comprises the transfer of organizing cutting assembly to turn to be used to making; Conduit is incorporated in the brachial artery; Conduit is advanced enter deep brachial artery, superior ulnar collateral artery, inferior ulnar collateral artery, radial artery, ulnar artery or humerus branch; To organize cutting assembly to be positioned near target location in deep brachial artery, superior ulnar collateral artery, inferior ulnar collateral artery, radial artery, ulnar artery or the humerus branch or its; Operate transfer by the first power is applied to transfer, the first power causes the distal portions of conduit at the radial direction upper deflecting; Move axially conduit, thereby allow rotatable tool from target location resection organization; And removing from the tissue of target location excision, thereby treatment blood vessel.

As noted here, if necessary, many-sided combination of device described herein, system and method can be combined.In addition, device, system and method itself is combined in this description scope of disclosure.

Description of drawings

Figure 1A is the perspective view that is suitable for removing from body cavity the system of clogged material according to of the present invention.

Figure 1B is the close up perspective view of the far-end (distal tip) of the system shown in Figure 1A, shows an embodiment of cutting assembly.

Fig. 2 A shows the perspective exploded view of the cutting assembly of Figure 1B.

Fig. 2 B is the perspective view of the two-piece type cutter shown in Fig. 2 A.

Fig. 3 A to Fig. 3 C shows the toolbox with dynamic housing, and wherein, shell (external shell) has groove cutter (flute cutter) as cutter with inner two.

Fig. 3 D shows the exploded view of the toolbox of Fig. 3 C.

Fig. 3 E shows the perspective view with the toolbox of the dynamic housing of removing material from the chamber wall.

Fig. 4 A and Fig. 4 B show the layout of the feature of the toolbox that prevents the injured blood vessel wall.

Fig. 5 A shows the perspective view of the modification of opening cutter (the open ended cutter) housing with interior inclined-plane.

Fig. 5 B shows the cross-sectional side view of the opening cutter of Fig. 5 A that 5B-5B along the line cuts open.

Fig. 6 A and Fig. 6 B show for the modification of removing the cutting assembly of tissue from body cavity.

Fig. 7 A to Fig. 7 F shows the other modification of the centring means (centering device) in the cavity.

Fig. 8 A is suitable for removing perspective view the partial cross section of distal portions of system of clogged material from body cavity, shows an embodiment that scans cover (sweep sheath).

Fig. 8 B shows the perspective exploded view with the other embodiment of the cutting assembly of single piece type cutter.

Fig. 9 shows the perspective exploded view with the other embodiment of the cutting assembly of two-piece type cutter.

Figure 10 shows the cutaway view of the cutting assembly shown in Fig. 8 A.

Figure 11 A shows the cut edge of passing shell nozzle.

Figure 11 B shows the side view of the cutting assembly of Figure 11 A.

Figure 11 C shows the front view of the cutting assembly of Figure 11 A, and shows positive rake angle.

Figure 12 is the perspective view of an embodiment of protective casing (guarded housing) with expansion part.

Figure 13 A to Figure 13 C shows the side view of the use of the device for excising with expansion part as shown in figure 12.

Figure 14 A and Figure 14 B show the other embodiment that has a plurality of front cutting surfaces and the protection cutter (shielded cutter) of groove cutting surfaces is arranged.

Figure 15 is the perspective view that has protective casing and comprise the cutting assembly at grinding core tip.

Figure 16 A and Figure 16 B show the modification that has a plurality of front cutting surfaces, back cut surface and the protection cutter of groove cutting surfaces is arranged.

Figure 17 is the perspective view of partial cross section of distal portions that is suitable for removing from body cavity the system of clogged material, shows catheter body, scans cover, torsional axis and transmission parts.

Figure 18 A and Figure 18 B show catheter body or scan the other possible modification of part.

Figure 18 C is the side view of replaceable embodiment that comprises the catheter body of many bodies designs (multi-body design), this design in maximization first bending and the longitudinal rigidity in the second portion in have minimum the loss of reversing.

Figure 18 D is the detailed view in the first and second cross sections of Figure 18 C, shows an embodiment of the dovetail design (dovetail design) in the first cross section.

Figure 18 E is the detailed view of replaceable embodiment in the first cross section of Figure 18 C, shows another embodiment of the dovetail design in the first cross section.

Figure 18 F is the side view of catheter body that comprises the many bodies design of Figure 18 C, shows crooked distal portions.

Figure 19 A shows catheter body and scans the interior transmission parts of framework.

Figure 19 B shows and is wrapped in an embodiment that reverses axial transmission parts, as shown in figure 17.

Figure 19 C shows the phantom of transmission parts and the modification of the torsional axis with back winding coil.

Figure 19 D shows the second transmission parts in the torsional axis.

Figure 19 E is the perspective view that comprises the replaceable torsional axis of the winding groove (coiling groove, wound groove) as transmission parts.

Figure 20 A be with the similar partial cross section of Figure 17 in perspective view, show the distal portions that causes conduit angular deflection scan framework.

Figure 20 B is the side view of the distal portions of the conduit shown in Figure 20 A, wherein scans framework and is in not bending position.

Figure 20 C be with partial cross section like Figure 20 category-A in perspective view, show and the part that scans that scans the framework adjacency, wherein scan the angular deflection that framework causes the distal portions of conduit, wherein, framework is scanned in crooked or compression, so that conduit is hinged until predetermined angular.

Figure 21 A to Figure 21 C shows the other modification of scanning framework of using with device for excising described herein.

Hinged around sweep of the distal portions that Figure 22 A shows conduit is to realize removing pathological tissues.

Figure 22 B to Figure 22 D shows the modification of scanning of cutting assembly, and wherein scanning can rotating 360 degrees or more.

Figure 22 E is the cutaway view of blood vessel, and the system that shows removes the ability of cavity in diameter equals four times blood vessel of conduit diameter.

Figure 23 A to Figure 23 H shows for passive by curved blood vessel and turn on one's own initiative and be diverted to the excision system for the treatment of position.

Figure 24 A to Figure 24 C shows device for excising and is helping the guiding seal wire by the use in crooked dissection and the clogged material.

Figure 24 D shows the layout of housing window in case stop loss the blood trouble tube wall, and shows the juxtaposition of conduit and blood vessel wall.

Figure 25 A shows the exploded view for the control handle of excision system, and handle is suitable for rotating and the hinged distal portions that comprises the conduit of toolbox.

Figure 25 B shows the side view in the partial cross section of handle seat (handle base) part, and the handle seat partly is suitable for holding the function element of control handle and with the function of control handle and the functional separation of conduit base (catheter chassis).

Figure 26 A to Figure 26 C shows the side view of the flexible distal portions of conduit, and conduit has the flexible distal length of scalable and is suitable for and may carries out the track rotation with uneven element.

Figure 27 is the perspective view of conduit base portion, and the conduit base portion is suitable for snap fit in handle seat part, and comprises be used to the controlling organization that turns to and scan, washes, aspirates and rotate torsional axis.

Figure 28 A is calibration box (indexing cassette) and relevant spring holder (spring-loaded plunger) with Figure 28 B, and as shown in figure 27, the calibration box is suitable for vernier control is carried out in toolbox deflection and steering characteristic with relevant spring holder.

Figure 29 A and Figure 29 B show the excision system, comprise the control handle for system, and handle is suitable for rotating and the hinged distal portions that comprises the conduit of toolbox.

Figure 30 shows the schematic diagram of excision system, this system's cutting fragment, and by conduit with fragment suction catheter base with from the pump orifice sucking-off.

Figure 31 A and Figure 31 B show the modification of scanning framework with visual properties, and when finder under the non-intruding imaging, this feature allows the doctor to determine hinged orientation and the direction of cutting assembly.

Figure 32 A to Figure 32 C provides the example of fluid delivery system.

Figure 33 shows and is configured to the fast modification of the device of exchange.

Figure 34 shows the example that makes the tip centering of cutting assembly at seal wire.

Figure 35 shows the cutting assembly of removing pathological tissues in support or coil.

Figure 36 shows the internal anatomy of the lower limb of animal (comprising the people), and shows the labelling of the tremulous pulse in the lower limb.

Figure 37 A shows the internal anatomy similar to Figure 36, and shows the offside structure of the possible in-position (access site) of using in the vascular system of removing pathological tissues.

Figure 37 B shows the detailed view of Figure 37 A, and this detailed view shows conduit 120, and it runs through external iliac artery, by curved vessel, and enters dark tremulous pulse with the excision obstruction.

Figure 38 A shows the internal anatomy similar to Figure 35, and shows the other possible homonymy in-position of the system that uses in the vascular system of removing pathological tissues.

Figure 38 B shows the detailed view of Figure 38 A, and this detailed view shows conduit 120, and it passes through wears the popliteal femoral artery, by curved vessel, and enters anterior tibial artery with the excision obstruction.

Figure 39 is reinforced as at multiple-piece tool kit (suite of tools, the view of one group of parts of the system that uses with its use instruction in kit).

Figure 40 A and Figure 40 B show the distal portions of ablation catheter, and ablation catheter comprises air bag (balloon) or other mechanism, support for the secondary vessel plasty, and/or other medicines carrier (drug delivery).

Figure 41 A and Figure 41 B are the side views of an embodiment of excision system, and this system comprises changer and/or sensor, with before treatment and/or the imaging at targeted treatment site (position) is provided afterwards.

Figure 42 is the side view of an embodiment of excision system, and this system comprises near the imaging system that is positioned at far-end or its, with before treatment and/or the imaging of targeted treatment site is provided afterwards.

The specific embodiment

Although present disclosure is in detail and accurate, can make those skilled in the art implement the present invention, actual embodiment disclosed herein only is that illustrate can be with the present invention of other concrete structure embodiment.Although described preferred embodiment,, can change details not deviating under the prerequisite of the present invention that is limited by claims.

This description discloses the various device based on conduit, system and methods for remove clogged material from body cavity, comprises the soft Elastic tissue of removing in speckle, thrombosis, calcium and the blood vessel.For example, various aspect of the present invention has application in the program that pathological tissues and/or the damaged portion of blood vessel need to be treated.The device, the system and method that embody feature of the present invention also are suitable for must not using based on system and the surgical technic of conduit.

Device, system and method especially are very suitable for the clogged material in continuously excision and the suction peripheral vasculature (comprising the tremulous pulse that exists in the lower limb, for example following limiting examples: femoral artery,common, femoral artery,superficial, deep femoral artery, popliteal tremulous pulse and tibial artery).For this reason, this device, system and method will be described in this article.Even so, must understand, disclosed device, system and method are applicable to treat other dysfunction of other places in the health (and nonessential relevant with tremulous pulse).

When mention by doctor or operator operation for remove from body cavity clogged material based on the equipment of conduit or device the time, term " near-end " and " far-end " will be used for describing when use equipment or its relation or direction with respect to the operator when installing.Therefore, term " near-end " will be used for describing when use towards the operator (, be in device " handle " end) location equipment or relation or the direction of device, and term " far-end " will be used for describing when using the equipment of locating away from operator (, be in " cutter " end of conduit or similarly away from handle) or position or the direction of device.

During partially or completely obstruction in the speckle in mentioning vascular or vascular or the organ, term " near-end " and " far-end " will be used for describing speckle or block relation or direction with respect to heart.Therefore, term " near-end " will be used for describing relation or the direction towards speckle or the obstruction of heart, and term " far-end " will be used for describing away from the speckle of heart (that is, towards foot) or position or the direction of obstruction.

I. system survey

A. system capability

Figure 1A and Figure 1B show the exemplary variation according to system 100 of the present invention, and system 100 is suitable for thrombectomy and/or speckle rotary-cut art.Go out as shown, system 100 comprises far-end (distal) toolbox 102 that is fixed to catheter body or conduit tube component 120, and wherein conduit tube component is connected to the control handle 200 of near-end.Should be noted that, the assembly shown in the figure only is used for exemplary purpose.The scope of present disclosure comprises the combination of possible various embodiments, and the combination of some aspect of various embodiments.

Compare with the device of existing excision type, system 100 provides quite simply use, performance and safety advantages.As will be by this description and accompanying drawing in greater detail; system 100 can comprise rotatable cutting, the protection (protection) that can 360 degree turns to or the cutter of opening at the far-end of conduit; wherein conduit connects with the hand held controller (that is, handle) that is suitable for allowing continuously excision and aspirating pathological tissues (from fresh thrombus to calcified plaque).When cutting, debris catching and is removed in conduit serially.

Device described herein, system and method have the pathological tissues of challenge when being particularly useful for other systematic treating, namely, in bifurcation, in curved artery and at the tremulous pulse that stands Biomechanical force (for example, peripheral arterial, for example, be arranged in knee or other intraarticular (will in the back in more detail describe)) pathological tissues.

Device, system and method also can be carried out a large amount of other treatments (processing), (for example comprise biopsy, tumor resection, fibroma treatment, undesired hyperplastic tissue, the prostata tissue that increases, or other undesired tissue (for example, hernia spinal disc material)) excision.Any device described herein, system and method also can be used as the instrument for the treatment of chronic total occlusion (CTO) or tremulous pulse total blockage.Flexibility described herein small-sized (low profile) conduit system allows to be easy to the contact treatment position and will reduce to minimum to damage or the indirect injury of surrounding health tissue.Owing to having the continuous sucking ability, can reduce or even cancellation element introducing, treatment and removal process in the pollution of surrounding tissue.In addition, suction can be used to the biopsy tissue sample is sent to the health outside, to detect with the conduit of staying original position.This helps the doctor to make decision in real time in the process for the treatment of malignant tissue.

The degree of depth that sheath on the toolbox 102 or housing engage by the restriction cutter keeps the controlled excision organized, thereby prevents that the doctor from cutting healthy surrounding tissue absent-mindedly.The desired locations guiding cutter 108 that the most advanced and sophisticated steering capability of system allows the doctor to remove towards tissue, and indirectly tissue injury reduces to minimum.By deflection cutter and this deflection of rotation with arc scan, conduit can excise larger plaque deposition thing, tumor or greater than the lump of organizing of conduit diameter.Therefore, can realize by little contact channels the excision of larger tumor, thereby will reduce to minimum to patient's damage.

Device described herein, system and method also can excise the narrow (stenosis) in arteriovenous (AV) the hemodialysis contact position (fistulae and synthetic graft), and remove thrombosis.For example, by removing the cutter housing and having made in the recessed catheter body of groove cutter, can construct suitable non-cutting thrombectomy catheter.

Device described herein, system and method also can be used to cut bone in the surgical procedure process that minimum is invaded, cartilage, conjunctive tissue or muscle.For example, comprise that cutting can be used to contact spine (spine) with the conduit of grinding core element, process (facetectomy procedures) to carry out laminectomy or facetectomy, thereby alleviate spinal canal stenosis.For this application, can be further catheter design be become by hard sleeve in its partial-length configuration or itself have rigid element, insert and guiding to help operation.

Also may with device described herein, system and method recover in the coronary circulation and cerebrovascular circulation in the opening of arterial disease tissue, by removal lesion tissue again with by excising the restenosis tissue in the support.

II. the technical characterictic of expecting

Excision system 100 can comprise the technical characterictic of various its availabilities of enhancing, now with described.

A. toolbox

1. cylindrical shell toolbox

Fig. 2 A shows the exploded view of the illustrative embodiments of front cutting tool assembly 102.In this modification, toolbox 102 comprises cylindrical shell 104, and it has and is positioned at being suitable on its distal face and allows cutter 108 to extend beyond the opening 107 of distal face.Cutter 108 can comprise one or more cut edges.In the embodiment shown, the cut edge comprises first group of cut edge 112 of extending along (or basically along) cutter 108 and only along the second cut edge 109 of the part extension of cutter 108.Although the quantity of cut edge can change,, typically, the cut edge will be with axis 111 symmetries of cutter 108.

Fig. 2 B also shows the modification of cutter 108, and it comprises the distal portions 90 (wherein, near-end cutter part 92 also can be called cutter core adapter 92) that is installed on the proximal part 92.Near-end cutter part 92 comprises the axle 94 that terminates in engagement tabs (mating piece) 140, and wherein engagement tabs 140 is contained in the opening in the front of far-end cutter 90.Toolbox 102 also can comprise guidewire lumen 130, to allow making seal wire pass toolbox 102 and device 100.

As described herein, cutter 108 is preferably made by hard wear-resistant material, for example, and sclerosis instrument or rustless steel, tungsten carbide, cobalt chromium, or the titanium alloy that has or do not have wear-resistant paint (coating), for example, titanium nitride.Yet, any material that generally is used for similar operation application can be applied to cutter.The outer surface of the near-end of cutter 108 is blunt typically, and is designed to lean against on the housing 104.Typically, these surfaces can be parallel with the inner surface of housing 104.

Fig. 3 A to Fig. 3 E shows the other modification of toolbox 102.In such modification, the leading edge of housing 104 can be used as front portion or forward direction cutting surfaces 113.In a modification, cutter 108 can be taper or circle, so that the front of cutter comprises circular or the part ball shape.Go out as shown, front cutting surfaces 113 can be on the outer surface of housing 104 bevel.Such oblique angle feature has reduced cutting surfaces 113 scratch or the otherwise danger of injured blood vessel wall.As noted above, when the distal direction in the body cavity 2 shown in Fig. 3 F moved forward device, front cutting surfaces 113 engaged with tissue or speckle 4 and with its removal.As discussed here, the feature of device 100 comprises the seal wire 128 that helps prevent device excessively to cut chamber wall 2.

Housing 104 can or be configured to and cutter 108 rotations, perhaps can be static, and as scraping formula surface, Wood-scoop formula surface or dental formulas surface.For example, Fig. 3 A and Fig. 3 B show a kind of modification, and wherein, housing 104 can be fixed to and allow whole cutting assembly 102 around the cutter 108 of catheter body 120 rotations.System also can comprise becket (cutting ferrule, ferrule) 116, it allows catheter body 120 to be bonded to toolbox 102.Becket 116 can be used as for the area supported of cutter 108 in toolbox 102 interior rotations.Shown in example in, cutting assembly 102 comprises for the adjacency that housing 104 is fixed to cutter 108 groove pin chamber (recessed pin cavities) 103.Fig. 3 B shows the cutaway view of the toolbox 102 of Fig. 3 A.Go out as shown, in this concrete modification, whole cutting assembly 102 is with respect to becket 116 rotations, and becket 116 provides area supported for rotary shell 104.The proximal part 92 of cutter 108 rotates in becket, and simultaneously, the near-end of housing 104 is around becket 116 rotations.

The variety of way that housing 104 can those skilled in the art be understood very much is connected with cutter 108.For example, housing 104 can be connected directly to or be fixed to cutter 108 by junction point 103, so that both rotate together.Replacedly, capable of regulating housing 104 is so that it rotates sooner or slow than cutter 108.In another modification, select actuating device (gearing) to allow housing 104 to rotate in the direction opposite with cutter 108.

The modification of cutting assembly comprises the cutter 108 that stretches out from front cutting surfaces 113 parts of housing 104.In other modification, cutter 108 can further extend from housing 104, and perhaps assembly can comprise the cutter 108 in the fully recessed housing 104.In some modification, can determine, to allowing to improve the removing of fragment, especially the distal portions at cutter 108 uses one or two that place of groove cut edge structure is arranged with the deepest part of the groove (flute) 110 on the cutting surfaces 113 of housing 104 and the cutter 108.

In any situation, there is groove cut edge 112 that fragment of tissue is pushed back in the conduit.The outer surface of cutting surfaces 113 can be level and smooth before housing approached, and was not subjected to the dissection of cut edge with protection chamber wall.When deflection cutting assembly 102, the outer surface of housing 104 becomes flushing chamber wall, and prevents that the cut edge from engaging with blood vessel wall.When moving forward toolbox, it removes the speckle 4 that stretches out from wall chamber 2, and the groove edge 112 that has of cutter 108 promotes fragment of tissue backward.

Fig. 3 C shows another modification of cutting assembly 102, and wherein, the housing 104 of cutting assembly 102 keeps static around catheter body 120 or becket 116, and simultaneously, cutter 108 rotates in becket.In this embodiment, the inside of becket 116 near-end 92 that can be cutter 108 provides area supported.Housing 104 can be fixed to becket 116, and also can be used as the area supported for rotary cutter 108.

Cutter 108 is with respect to housing 104 rotations, thereby, cutting surfaces 112 on the cutter 108 is sheared or the tissue of riving, and will organize and catch in housing 104, thereby, can utilize the impetus of helicla flute 110 and on proximal direction, will organize discharge from the vacuum of torsional axis 114 and/or transmission parts 118.

Fig. 3 E shows the exploded view of the cutting assembly of Fig. 3 C.Equally, cutter 108 can comprise distal cut part 90 and proximal cut part 92.Shown structure provides a kind of device, and its distal portions 90 at cutter has less cut edge 112, and has the cut edge 109 and 112 of increase in proximal cut part 92.Yet modification also comprises traditional groove cutter that has.Around cutter part 90 and 92 holder housings 104, and, alternatively housing 104 is fixed to catheter body 120 or becket 116.As noted above, housing 104 also can be fixed to cutter, so that it rotates with cutter.

In interchangeable modification, the matching surface 140 of toolbox 102 can be used as blunt buffer at the most advanced place of cutter 108, and it has the open distal end design of toolbox as the buffer that prevents unexpected incision seal wire or blood vessel wall.In other modification, housing 104 can be extensible (for example basket or net).When cutter 108 rotated in housing, housing can be suitable for launching to cut larger diameter.

Fig. 3 F shows the cutting assembly 102 of cutting surfaces 113 before opening far away 117 places of housing 104 have.Housing 104 is together with cutter 108 rotations, to help to remove tissue.As noted above, when the distal direction in body cavity 2 moves forward device, front cutting surfaces 113 and tissue or speckle 4 meets and with its removal.As discussed below, the feature of device (comprising seal wire 128) helps prevent device excessively to cut chamber wall 2.

Fig. 4 A and Fig. 4 B show the toolbox 102 that is suitable for cutting forward.This embodiment comprises opening housing 104, and wherein, cutter distally extends from housing.Yet the blunt buffer 119 of the far-end of cutter 108 is as preventing the unexpected buffer of cutting seal wire 128 or excessively cutting chamber wall 2.In addition, this embodiment can comprise alternatively on the rear end of toolbox 102 that other housing parts 121, toolbox 102 partly cover cutter 108 and prevent that it is deeper in the side incision chamber wall 2.

With reference to Fig. 2 A, torsional axis 114 outside catheter body 120, scan framework 250 and becket 116 interior rotations, with rotary cutter and at proximal direction pulling or aspirate tissue fragment.Can be with the gap between catheter body 120 and the transmission parts 118, and the pitch of transmission parts 118 and the depth of thread be chosen to provide the pumping efficiency of expectation, as describing in more detail in the back.

Shown in Fig. 2 A, becket 116 can have the far-end area supported, with the supporting cutter 108 proximal end face, and with cutter shaft to stable remaining in the housing 104.In the situation that housing is static, can use scolder, brazing, welding, binding agent (epoxy resin), swaged forging, ripple (crimped), be pressed into cooperation, with screw thread screw on, snap lock or otherwise fixing with becket 116 housing 104 that bonds rigidly/be connected to.Go out as shown, becket 116 can have hole or other coarse features, and this feature allows to be connected with catheter body 120.Although in structure, can adopt binding agent and hot melt, not need such feature.Usually, for little Surface Contact, binding agent is insecure, and hot melt can cause catheter body 120 to be degenerated.

It is short that the use of mechanical lock fixed ring 126 allows cutting assembly 102.Such feature is for when needing by the knee (tortuousity) in the blood vessel, is important with the maximum flexibility of the distal portions 122 of conduit 120.In a modification, ring or belt 126 can be curved with becket 116 on catheter body 120.This will encircle/and part and the catheter body of belt be driven in the opening of becket 116, allows the strength increase between toolbox 102 and the catheter body 120.

Fig. 5 A and Fig. 5 B show corresponding perspective view and the cross-sectional side view of another modification of opening cutter housing 104.Go out as shown, cutter housing 104 comprises the opening 107 on the front that is positioned at cylindrical shell 104.In this modification, the leading edge 113 of housing 104 can be used as front or (forward) cutting surfaces forward, and has inclined-plane (beveled surface) 177 at the inner surface of housing 104.Such bevel feature has reduced cutting surfaces 113 is driven into the danger of blood vessel wall.Go out as shown, some modification of cutter housing 104 comprise the area supported 178 that is positioned at housing 104.In other modification, remove the degree of tissue in order to control cutting assembly 102, the far-end of housing 104 or cutting surfaces 177 can be crenate or jagged.For example, replace uniformly, cutting surfaces 177 can change (for example, the jagged edge of cutter extends along the axial length of housing) in the axial direction along the circumferential of housing.

The other modification of opening toolbox 102 comprises the revolving wormgear shape coring cutter (coring cutter) 172 shown in Fig. 6 A and Fig. 6 B.Fig. 6 B shows the side view of coring cutter 102.In use, can hydraulically promote this coring cutter, to drive sharp edges by tissue.Turbine-like cutter 172 has helical blade 174 in the inside of sharp cylindrical shell 176.

The element of coring cutter 102 also can have spoke or the centring means 184 shown in Fig. 7 A to Fig. 7 F, so that housing 104 is felt relieved around seal wire.Alternatively, centring means 184 can comprise the element of seal wire 128, goes out as shown.This helps to keep for safety the center of the cutting hands blood vessel wall of speckle.Spoke 184 is also as the pusher that retracts stenotic tissue, and this help drives forwards cutter and realizes suction, so that thromboembolism is minimized.

2. protective casing toolbox

A. construct the cut edge

Fig. 8 A shows the modification of tissue removal or excision system 100, and wherein, toolbox 102 is positioned at protective casing 104.In this modification, toolbox comprises first group of cut edge 112 and second group of cut edge 109, and wherein, the first cut edge 112 can be extended along the whole length of cutting assembly 102 (that is, be exposed in the opening 106 of housing 104 whole length).On the contrary, only extend along a part second group of cut edge 109 (in the drawings, only can see second a such cut edge).Yet the modification of device described herein, system and method can comprise any amount of as described herein or construct such as the known cutter of those of skill in the art.In addition, although shown system 100 has illustrated a plurality of openings 106 in housing 104,, interchangeable cutting assembly 102 can be included in the housing that has single opening on the face far away, and is as described earlier.

Fig. 8 B shows the modification of cut edge, and it comprises first group of cut edge 112 of extending along (or basically along) cutter 108 and only along second group of cut edge 109 that the part of cutter 108 is extended.Although the quantity of cut edge can change,, typically, the cut edge will be about axis 111 symmetries of cutter 108.For example, in a modification, shown cutter 108 will have a pair of the second cut edge 109 and a pair of the first cut edge 112 that arranges symmetrically with regard to the axis 111 of cutter 108 that arranges symmetrically with regard to cutter 108.Therefore, such structure produce two on the distal portions that is positioned at cutter 108 cut edge 112 and the cut edge 109 and 112 on four proximal parts that are positioned at cutter 108.

Be provided at the cutter 108 that has less cut edge on the distal cut part and have the cut edge of a greater number in the proximal cut part, allow the stronger cutter sweep of cutting power.Go out as shown, cutter 108 can be configured to have close groove (grooves), the cut edge 109,112 (wherein, this combination is called as " cut-in groove ") of passage or groove (flutes) 110.Cut-in groove 110 is for cutting material provides the path, with by system 100 from treatment position out, and improves the motive force that is produced by cutter 108.Helical groove 110 and sharp cut edge 112 can be parallel to each other, and can with the cutter rotating photo with meaning on be wound to far-end from near-end.When cutter 108 rotation, it becomes the pusher that causes the movement of fragment of tissue near-end ground, with its discharge.

By reducing the quantity of the groove on the cutter distal portions, can make groove darker.Darker groove allows the cut edge near groove, to remove more material.Yet the size that increases material also can increase the material caking ability or pass through the probability that conduit 120 slowly moves in the removal process.In order to alleviate this possible problem and to increase the efficient of transporting material by conduit, cutter can be configured to have towards the cutter rear portion cut edge of quantity increase, this reduces the size of incision of matter by the second cutting that material is provided, further to reduce the material size, transport thereby improve.

Be exposed to the cut edge 109 in the housing 104,112 quantity by control by opening 106, can control the relative quantity (Cutting Length and depth of cut all can be controlled the material volume that cutter is removed at each finite element rotation) that cutting engages.These features allow the independent control of the maximum twist load in the system that puts on 100.By careful selection groove and/or cut edge 112 geometry with respect to the opening 106 in the housing 104, further control torque balance.For example, when when passing housing window 106 and expose cut edge 112 and/or 109, cause putting on torsional load in the system by the shearing of tissue.If all cutter edges are sheared simultaneously, so as an example, when the quantity of housing window was the even-multiple of cutter amount of edge, moment of torsion was along with cutter rotating circulating ground changes.By regulating the quantity of cutter and window, so that one be not another even-multiple (for example, by using five windows 106 at housing and using four cut edges at cutter 108), in the process of each rotating circulating of cutter 108, can have more uniform moment of torsion (removing tissue from shear action).To understand, for all toolbox embodiments described herein, above-mentioned cut edge structure is obtainable.

The geometry of cutter 108 and housing 104 can be used to the degree of dissection of adaptive expectation.The direction of housing 104 and opening 106 can be used to limit the depth of cut of cutter 108.In addition, the far-end of housing 104 can be dome-shaped, and simultaneously, near-end can have cylindrical shape or other shape.For example, by in housing, producing larger hole or window 106, can expose the major part of cutter 108, and increase cutting speed (for given rotary speed).Place by cutting window 106 on the projection or sidewall 105 of housing 104, if with the cylindrical shape part that window 106 is placed housing on compare, excision efficient pair and aiming at of cutter housing 104 and pathological tissues are sensitivities still less.This is the key performance restriction of traditional direction rotary-cut art conduit.In addition, window 106 is placed on the projection of housing and can cause secant effect (as described below).

B. toolbox is constructed

Fig. 9 shows the exploded view of toolbox 102 and becket 116.In this modification, toolbox 102 comprises housing 104, and it has three about the sidewall 105 symmetrically arranged openings 106 of housing.Fig. 9 also shows the embodiment of cutter 108, and it comprises the distal portions 90 (wherein, near-end cutter part 92 also can be called cutter core adapter) that is installed on the proximal part 92.Near-end cutter part 92 comprises axle 94, and it ends at for the engagement tabs 140 that cutter 108 is engaged to housing 104 (wherein, engagement tabs 140 is held in (cover) center cavity 142 in the front of housing 104).Cutter 108 also can comprise for the passage 130 that seal wire is passed system 100.

Although system 100 of the present invention comprises the embodiment of the cutter that integral body (in unitary body) forms,, provide the cutter 108 with far-end cutter part 90 and near-end cutter part 92 can allow the optimal choice of material.In addition, go out as shown, the first cut edge 112 can be extended along two cutter parts 90,92, and simultaneously, the second cut edge 109 can only be extended along near-end cutter part 92.For this structure, when cutter part 90,92 connected to form cutter 108, the distal portions 90 of cutter only comprises two the groove cut edge, and simultaneously, proximal cut part 92 comprises that four have the groove cut edge.Naturally, any amount of have the groove cutting part all within the scope of the invention.Yet modification comprises, with respect to the quantity of the cut edge on the near-end of cutter 108, has still less cut edge at the far-end of cutter 108.In addition, the cut edge can arrange symmetrically or asymmetrically about cutter.

Figure 10 shows the housing 104 with distal end nose, and the distal end nose band is useful on the center cavity 142 of the engagement tabs 140 of holding cutter 108.Such feature helps to feel relieved with one heart cutter 104 in housing 104.As described below, the modification of toolbox 102 comprises the increase of grinding core element or expansion part, and the grinding core element is used for grinding sclerous tissues's (for example, calcified plaque), and expansion part is used for towards opening 106 separate substances.

Figure 11 A to Figure 15 shows various other examples of cutting assembly 102, and cutting assembly 102 comprises the protective casing 104 with system's 100 combinations.

Figure 11 A shows Fig. 8 A, Fig. 8 B and cutting assembly shown in Figure 9, and wherein, opening 106 forms helicla flute in housing 104.Opening 106 can be aimed at or can not aim at it with the cut edge 109,112 of cutter 108.For more effectively cutting, groove 106 and cut edge 109,112 can be aimed at, be exposed to the tissue of cut edge with increase.In other words, cut edge 109,112 and opening 106 can aim at (in line), thereby all cut edges 109,112 are exposed simultaneously, cut simultaneously allowing.Replacedly, opening and edge 109,112 aim at can be set, thereby, be not that all cut edges 109,112 expose simultaneously.For example, aligning can be such, so that when a cut edge was exposed by an opening 106, remaining cut edge was hidden in the housing 104.The modification of such structure allows to expose any amount of cut edge in any given time.In addition, the modification of Figure 11 A description shows enough large window or opening 106 to expose the first cut edge 112 and the second cut edge 109.Yet, in interchangeable modification, window one-tenth only can be exposed cut edge 112 at the far-end of cutter 108.

Be suitable for making the torque diagram of device to flatten in the smooth modification at another when when cutting, can construct cutter 108, so that the edge/cutting surfaces 109 of aiming at shell nozzle 106 of groove (flutes) 110,112 quantity do not change in rotating circulating.This prevents that conduit has torque peak (torque spike) and overload and produce the circulation change in torque owing to a plurality of cut edge/grooves engage with tissue synchronization.In other words, the length of the cutting surfaces 112 that exposes of the opening by housing 104 106 keeps identical or keeps constant.

In the modification shown in Figure 11 B, cut edge 109,112 is configured to catch the fragment in the groove 110 when cutter 108 rotation.Typically, cutter 108 is designed to have the secant effect.This effect allows the just tissue of cutter 108 to engage.When cutter 108 rotated by opening, the cut edge was passed arc and is moved, and wherein, in arc apex, stretch out above the plane of opening 106 a little the cut edge.Can be by selecting outreach to control the amount of just organizing joint with the suitable design (for example, by the position of composite window 106 and the radius of curvature of size and housing 104) of housing geometry.When it rotated, cut edge 109 or 112 can be passed window 106 and stretch out from housing 104.Also this structure can be designed to fragment is driven or be pushed to transmission parts 118 (referring to Fig. 2 A).In this case, the groove 110 in the cutter 108 is slotted spirally, to keep fluid to be communicated with transmission parts 118.

Figure 11 A and Figure 11 B also show at far-end has inflection shape (profile) and near the surface of the cutter 108 on the surface of housing 104.Should be noted that the shell nozzle 106 with this curved shape allows cut edge 112 to stretch out the outer surface of housing.In other words, opening 106 forms secant at the curved surface of housing 104.Such feature allows the improvement cutting of the larger material (for example, calcification or hard fibrous tissue) of harder/rigidity, and wherein, housing 104 is not stretched in such organizing.

Shown in Figure 11 C, the modification of cutter 108 can have the cut edge 109,112 with orthogonal rake α,, the direction identical with the cutter direction of rotation is pointed in the cut edge that is.This structure will promote and the maximizing efficiency of dissection (by nip tissue and avoid organizing deflection).

Figure 12 shows the modification of toolbox 102, and wherein, the housing 104 of toolbox 102 comprises from the extension (extension) 133 of conical, taper or the expansion of extending previously of housing 104.Expansion extension 133 is applicable to many purposes, that is, it can help prevent cutting assembly 102 injured blood vessel walls.In addition, if pillar to intrinsic deflection, then the enhancing structure of the increase of the front of housing 104 has reduced the probability of rotary cutter 108 actual incision housings 104.Yet a key character of expansion extension 133 is that it provides from seal wire to housing the opening 106 tapered surfaces 104.Therefore, when expansion extension 133 advanced by clogged material, expansion extension 133 forced or distention substance, make its towards opening 106 and cut edge away from seal wire.For distention substance makes it away from the center of toolbox 102, expansion extension 133 must have enough radial strengths.In an example, can make expansion extension 133 and housing 104 by integral material as discussed here.

Expansion extension 133 typically comprises the opening 130 for silk guide passage.In addition, in most of modification, the front end 135 of expansion extension 133 will be circular, to help mobile clogged material on the surface of dilator 133.In addition, the surface of expansion extension 133 can be level and smooth, to scan cutting assembly 102 with allowing following discussion.Replacedly, expansion extension 133 can have a large amount of longitudinal flutings, material is introduced opening 106.In other modification, expansion extension 133 can not comprise opening 130.In such a case, expansion extension 133 can be tapered to closing end fully.

Figure 13 A to Figure 13 C shows the use of the system 100 that comprises expansion part (dilating member) 133.In this modification, move forward device 100 at seal wire 128.Yet the use of seal wire 128 is optional.When device 100 during near speckle or clogged material 4, expansion part 133 forces speckle 4 away from the center of system 100, and the opening 106 in cutting assembly 102 moves, shown in Figure 13 B.Apparently, expansion part 133 must have enough radial strengths, thereby it forces obturator to move towards opening 106.Yet, be in those modification of taper shape or taper at expansion part 133, towards opening 106 mobile speckle material 4 gradually.In not having those devices of expansion part 133, the doctor must apply extra power, to face toward speckle 4 moving cutting tools.Do not comprise in the excessive situation of expansion part 133 at some, cutter can the cutting tool housing, causes failure of apparatus.

Figure 13 C shows the situation that whole obturator 4 passes in system 100.Yet, describe in detail such as the back, can be with device construction in vascular, to scan.Like this, the doctor can be chosen in and scan system 100 in the obturator, to open obturator in passing the process of obturator or after passing obturator generation path.In arbitrary situation, the character of expansion part 133 is also as keeping cutting assembly 102 and blood vessel wall 2 to separate.

Figure 14 A and Figure 14 B show another modification of the cutting assembly 102 of cutting surfaces 113 before the distal portions of cutter 108 has.In this modification, cutter housing 104 can comprise two or more larger openings 106, and cutting surfaces 113 engages with tissue before it allows when far end party moves up.Cutter 108 also can comprise a plurality of groove cut edges 112 that have.

As shown in figure 15, toolbox 102 also can have the grinding core 180 that stretches out from its distal portions.Although grinding core 180 can have the abradant surface of any type,, in a modification, this grinding core 180 is blunt and has fine granularity (for example, diamond grit), to allow in the situation that do not damage the tissue that adjacent soft tissue grinds severe calcification.This combination of grinding core 180 and cutter 108 allows toolbox 102 to utilize grinding core 180 (for example to remove hard stenotic tissue, calcified plaque), simultaneously, the cutting tool 108 of sharp edges is removed softer tissue (for example, fibrous tissue, fatty tissue, proliferation of smooth muscle or thrombosis).In modification, grinding core 180 also can have helicla flute to help suction, and perhaps grinding core can be combined in the part of cut edge (for example, the farthest part of cutter 108).

C. far-end and proximal cut

Figure 16 A and Figure 16 B show the other modification that is suitable for the cutting assembly 102 of system's 100 uses.Figure 16 B shows the side view of the toolbox 102 of Figure 16 A.In this embodiment, cutting assembly 102 comprises larger window 106, comprises the cutter 108 of a plurality of directional cuttings surface 112,113 and 115 to hold (accommodate).When cutter 108 during in housing 104 interior rotation, there is groove cut edge 112 cutting with the tangent direction of the direction of rotation of cutter 108.In other words, groove cut edge 112 incision of matter are arranged, this material approximately is the periphery of cutter 108 when it rotates.Cutter 108 also comprises one or more front cutting surfaces 113 and back cut surface 115.When conduit in forward direction or when rearward moving up, these cutting surfaces 113,115 engage with tissue.It is important being shown as for effective excision in the ability that a plurality of directions engage and removal is organized.Yet the modification of the cutter 108 among the present invention can comprise the cutter 108 with one or two directional cutting surface.For example, have groove cut edge 112 can with arbitrary front cutting surfaces 113 or back cut surface 115 combinations.The ability of excising in forward, backward and direction of rotation has also reduced toolbox from probability firm or hard tissues deflection.

B. conduit tube component

1. catheter body

Figure 17 shows the distal portions 122 of the rotary-cut art system 100 with the toolbox 102 that extends from catheter body 120.As below discussing, catheter body 120 can engage with rotating mechanism or motor 150, is contemplated to be in handle 200, and it finally drives toolbox 102 by torsional axis 114.

Usually, in order suitably to excise the tissue in the vascular, desirable system 100 comprises that the enough enough juxtaposition power (bending rigidity) of energy supports the conduit 120 of toolbox 102.Catheter body 120 should have enough moments of torsion (that is, having enough torsional rigidities), thereby the doctor can point to toolbox 102 angle position of the expectation in the vascular 2.System 100 should also be (that is, the having enough post rigidity) that can enough promote, and allows suitable cutting when organizing to pass when the surgeon pushed on device.Yet, must weigh these demands and make the device that meeting really up to the mark becomes and can not reach reliably crooked dissection or have angle to dissect.For these demands of balance, the modification of system 100 can have more flexibly remote location 122 (for example, as limiting examples, in the end in the 10cm), to improve guiding (navigation) in crooked dissection the (for example, comprise on the seal wire trace ability).Because integral rigidity (in compression and the moment of torsion) depends on the total length of conduit 120, but guiding is affected by remote area 122 mainly, so the method is a kind of mode of optimizing simultaneously several variablees.

For increasing moment of torsion and another design of promotion be that braiding structure (braid) the structure catheter body 120 from the winding around and/or scan part 270 (will discuss in more detail below) is with optional polymer jacket coating.This compound structure can be by the polymer bushings of making such as the material of PTFE (polymer liner).Another modification comprises by the catheter body 120 of metal tube manufacturing and/or scans part, metal tube along pipe (for example has, rustless steel or Nitinol) the selectivity otch of length, the expectation that produces rigidity (crooked, reverse and compress) with the length along conduit 120 distribute (profile).This slotted metal Guan Kecheng the linear alignment, or cover has polymeric material, and can further be treated to and produce hydrophilic, hydrophobicity or medicine in conjunction with (binding, binding) (heparin, antibacterial) performance.Structural application described herein is in any device for excising described herein.

Catheter body 120 also can form by strengthening sheath, for example, be clipped in for example high density polyethylene (HDPE) (HDPE), polyethylene (PE), politef (fluoropolymer) (PTFE), the metal knitted structure (metal braid) in the polymeric matrix of the material of nylon, polyether block amide (PEBAX), polyurethane and/or silicone.Sheath is harder at far-end at the near-end ratio.This can be by not having metal knitted structure to realize at far-end with the polymer of softer grade and/or at far-end.

Figure 18 A to Figure 18 F shows can be in the possible modification of making catheter body 120 and/or scanning the compound structure that adopts in the part 270, and this compound structure is used for excision described herein system.Figure 18 A shows the compound structure 290 of slotted-tube 292, and wherein, pipe for example can be selected from, polymer, metal (for example, rustless steel), or marmem (for example, the superelastic Nitinol pipe), or combination wherein.Pattern along pipe 292 groove can be customized to the characteristic that realizes expectation, for example, and along the classification rigidity of long axis and/or the minor axis of catheter body 120.Structure 290 can comprise inner surface and/or the polymer coating in the outer surface, sleeve or the lining (liners) 298 of pipe 292 alternatively.

Figure 18 A also shows as having the pipe 292 of first area 294 and second area 296, and wherein, the frequency of groove is different between the zone.Adopt any amount of slotted-tube structure (for example, those appear at the structure in the medical treatment device that is designed to lead to bending area) in can the design here.In the time of in being incorporated into speckle rotary-cut art-and band is just like the ablation catheter that scans framework described herein, and such design provides significant and unexpected improvement in the turning to and cut of pathological tissues.

Figure 18 B shows can be in catheter body 120 and/or another modification of scanning in the part 270 compound structure 300 that adopts, to use with the modification of excision described herein system 100.Go out as shown, structure 300 comprises the coil piece 302 that is covered by braiding structure 304.Coil and braiding structure can be made by general known any material in the field of braiding structure/coil conduit respectively.For example, can be by super-elasticity wire thing or ribbon coiling 302.And braiding structure can comprise super-elasticity or the stainless steel filament of a plurality of braidings or weave in.Figure 18 B also shows the braiding structure 304 that is covered by polymer coating, sheath or lining 306.

In other modification, catheter body 120 and/or scan part 270 and can comprise the helical cut pipe that is covered by lining or polymeric layer.In such a case, can select helical angle and width, with the characteristic of applicator expectation.For example, can select helical angle, but to maximize the promotion of device, simultaneously, when rotating or scanning cutting assembly, keep the approximate one-one relationship between cutting assembly 102 and the device near-end.

Figure 18 C shows the catheter body 120 of using with the modification of excision described herein system 100 and/or the another modification of scanning part 270.As can be seen, catheter body 120 can comprise many body designs, and this design has the minimum loss of reversing, and simultaneously, the longitudinal rigidity among the bending among the 120A of first and the second portion 120B is increased to maximum.The 120A of first is shown as has the dovetail structure that is suitable for the predetermined expansion between the dovetail feature, and controlled motility is provided.Second portion 120B is shown as the helical cut pattern of the Line To Line cooperation with generation support, and it produces the continuous material of spiral series, transmits with the nothing bending that keeps reversing stretching and compressive load.But this embodiment also can comprise elastic overcoat or inner sleeve, or is suitable for flexibly limiting the extension of dovetail component axial the sheath (chuck) 125 that allows distal portions 120A to radially bend.

Figure 18 D and Figure 18 E show the detailed view of the embodiment of the first and second part 120A and 120B, show the optional structure of dovetail feature, and wherein, Figure 18 D shows traditional dovetail structure, and Figure 18 E shows curved configuration.Should be appreciated that, other structure also is possible.Figure 18 F shows the catheter body 120 that radially bends the position, shows the 120A of first by the bending of the arc expansion of dovetail structure.

Can apply coating to the moving component in the conduit 120 to reduce friction.In one embodiment, conduit 120 and torsional axis 114 are coated with hydrophilic coating (polyvinyl alcohol), to reduce the friction between the moving component in the conduit 120.Coating also can be hydrophobic (for example, Parylene, PTFE).Available heparin dip coating is in use to reduce lip-deep blood coagulation.

2. torsional axis and transmission parts

Figure 19 A shows the phantom of modification of the distal portions 122 of system 100, the layout that it shows catheter body 120 and scans the torsional axis 114 in the framework 250.Go out as shown, this modification of system 100 comprises the transmission parts 118 on the outer surface that is positioned at catheter body 120 and is positioned at torsional axis 114.Transmission parts 118 can be spiral system or Archimedes's formula screw, and it transports fragment and the material that produces in processing (procedure) process, makes it away from surgery location.In any situation, transmission parts 118 can have surface or the blade of increase, and it drives material away from surgery location (referring to Figure 19 B) at proximal direction.Such material can be sent to the container of health outside, perhaps, can be with such material storage in system 100.Torsional axis 114 and transmission parts 118 can extend along the total length of conduit, and may stretch in the handle 200, and perhaps, transmission parts may only extend along a part of length of conduit 120.Go out as shown, torsional axis 114 and transmission parts 118 are scanning framework 250 interior cooperations.In some modification of system 100, can scan arrange between framework 250 and the torsional axis 114 lid or thin film, to prevent that debris catching is in the sawtooth that scans framework 250, groove or opening 252.Lid or thin film also can be used as smoothly, the low surface that rubs.

Figure 19 C shows the partial cross section figure for the replaceable example of the torsional axis 114 that engages with toolbox 102.In order to help to remove material, torsional axis 114 can be the coil of one group of reverse-winding, and wherein exterior loop is twined with suitable (larger) pitch, to form transmission parts 118.Oppositely winding around can automatically strengthen torsional axis 114 in rotary course each other.Replacedly, torsional axis 114 can be made by rigid material (for example, plastics), shows to such an extent that have a flexibility by comprising spiral salient (spiral relief) as transmission parts 118 or groove.Although axle 114 can be made by any standard material, but the modification of torsional axis can comprise metal knitted structure and/or one or more wire coil that contains in polymer (for example following limiting examples: PEBAX, polyurethane, polyethylene, fluoropolymer, Parylene, polyimides, PEEK and PET).These structures will increase to maximum for the torsional strength of " but promotion " and rigidity and post intensity, and will reduce to minimum for the rigidity of " motility ".Such feature is important for making conduit by curved vessel, but allows to transmit reposefully on the length of conduit moment of torsion.

In the multi-coil structure, should twine interior loop with rotating photo direction together, thereby it will trend towards opening under torsional resistance.This has guaranteed that guidewire lumen 130 stays open in rotary course.Should relatively twine exterior loop (transmission parts) 118 with interior loop, with reverse expansion, thereby keep the interior loop wrapping to rely on conduit 120.

Typically, guidewire lumen 130 will be used for transmitting seal wire.In such a case, center cavity 130 can be coated with lubriation material (for example, such as hydrophilic coating or Parylene) or (for example, PTFE) be made, combine with seal wire avoiding by lubriation material.Yet in some modification, the seal wire partial fixing perhaps is fixed to toolbox housing 104 (that is, exchange will be described later fast) to the outer distal portions 122 of catheter body 120.In addition, the center cavity 130 of torsional axis 114 also can be used to fluid and seal wire side by side are sent to surgery location, or is sent to the appropriate location of seal wire.

In some modification, transmission parts 118 can be made one (for example, by with transmission parts 118 incision torsional axiss 114, or by torsional axis 114 directly being squeezed out helicla flute or extension (protrusion)) with axle 114.In the other modification shown in Figure 19 D, additional transmission parts 118 ' can comprise (combination) on the inside of torsional axis 114, wherein, inner transmission parts 118 ' is relatively twined with outside transmission parts 118.Such structure allows suction fragment (by outside transmission parts 118) and injects (by inner transmission parts 118 '), and perhaps vice versa.Such dual function can strengthen by following effect the ability of excision and suction speckle: (1) makes blood thinning, only make viscosity thinning or (for example increase anticoagulant, heparin or Warfarin (warfarin)) and/or such as the antiplatelet drug of clopidogrel (Clopidogrel), (2) improve the pumping (suction) of excising speckle by converting it into the solid-liquid slurry that shows better pumping efficiency, and/or (3) are set up and will directly do not cut the mobile control householder method of catching embolus (thromboembolism) of housing by setting up the local recirculation zone.

As raised above, can on the direction meaning identical with cutter 108 and in identical direction of rotation, twine transmission parts 118, to affect the suction of fragment of tissue.The impetus of cutter 108 shifts out fragment of tissue from the opening 106 of housing 104,107 inside, through cut edge 112 and 109, further grinding fragment, and enter torsional axis 114.The spacing of cut edge 112 (pitch, pitch) can with the pitch match of transmission parts 118, with further optimization suction.Replacedly, can change the spacing of transmission parts 118, in case when material enters transmission parts 118, can increase its translational speed.As discussed herein, can be by discharging health is outside along transmission parts 118 effects of the part of catheter body 120 or total length and with fragment, and receive aid or be not under the help of the vacuum pump 152 that is connected with conduit handle 200.Replacedly, fragment can accumulate in the system 100 or be attached in the bin of system 100.

It may be favourable that torsional axis 114 is engaged (need not physical contact) with the rotation of driver element 150 electromagnetic grounds.For example, torsional axis 114 can have the magnetic pole that is installed in the near-end in the tubular structure, and this tubular structure is attached to and reverses axial sheath.The stationary part of motor 150 can be embedded in the handle 200 of tubular structure.This will allow by catheter body 120 continuous suckings, and need not to use the high speed rotating sealing.

3. scan framework (sweep frame)

Figure 20 A to Figure 20 C further shows an embodiment that scans framework 250 that is positioned at catheter body 120.Scan the axial length L of distal portions 122 that framework 250 can be suitable for allowing conduit 120 in response to the close end office that typically is applied to conduit or be applied to the power at handle 200 places of system 100 and crooked or hinged.Can provide in every way applied force, for example, in the far-end guiding, in near-end guiding and/or rotation or any combination.

In the embodiment shown, scan framework 250 comprise have a plurality of sawtooth, the tubular construction of groove or semi-circumference opening 252.Generally, provide the part of the post intensity that reduces on by first radial side 254 (that is a side that, comprises opening) of scanning framework and framework 250 is died down scanning zone that framework 250 has an opening 252.The post Strength retention of the not weakened part of scanning framework 250 256 is greater than the post intensity of first radial side 254 of scanning framework 250.When axial force 264 being applied to when scanning framework 250, drive it towards standing part (for example, the part of toolbox 102 and/or catheter body 120), the deflection of the distal portions 122 of this structure permission system 100.In interchangeable embodiment, for example, axial force can be applied to conduit 120 or torsional axis 114, this power drives standing part (for example, toolbox 102) towards scanning framework 250, and causes distal portions deflection.Shown in Figure 20 C, framework 250 is scanned in this axial force compression, causes having the zone compression (that is, the side of scanning framework 250 near opening 252 is moved toward each other in the first radial side 254) of the post intensity that weakens.This causes again spine (spine) or strengthens side 256 at the direction upper deflecting towards the first radial side 254.Because scan framework 250 can with catheter abutment (for example, it can completely or partially be encapsulated in the catheter body 120), so scan far-end 122 that the deflection of framework 250 causes catheter body 120 and toolbox 102 in the deflection 262 on the direction of the first radial side 254, cause the axis and the axis angulation A that scans the proximal part 258 of framework 250 of toolbox 102.

Scanning framework 250 can be independent of rotatable tool 108 and torsional axis 114 and rotate.In some modification, scan framework 250 and also can rotate independently with catheter body 120.In such structure, when deflection scan framework 250 rotation the time, cutting assembly and/or distal catheter part 122 are mobile at curved path with respect to the axis 260 of the near-end 258 that scans framework 250.Scanning framework 250 can also be configured to catheter body 120 rotations.In a kind of structure, toolbox 102 also can be with scanning framework 250 rotations after this, and simultaneously, rotatable tool 108 still can be independent of and scan framework 250 rotations.

Figure 21 A to Figure 21 C shows other modification of scanning framework 250 of using with cutting assembly 102 described herein and conduit 120.For the outstanding framework 250 that scans, omit torsional axis 114 from Figure 21 A to Figure 21 C.Yet as shown in figure 17, for example, torsional axis 114 can run through and scans framework 250, wherein, and torsional axis and scan framework and can rotate independently of one another.

Figure 21 A shows the perspective view of excision system 100, wherein, partly removes catheter body 120 so that the modification of scanning framework 250 to be shown.In this modification, can scan framework 250 from the laser cut tube structure with sawtooth, opening or groove 252.Opening 252 produces weakening part along first radial side 254 of scanning framework 250.The side 256 relative with the first radial side 254 comprises the zone of the post intensity of increase.Therefore, when the doctor typically by scan part 270 when the near-end of system 100 applies axial force (for example, on distal direction), as discussed below, axial force causes scanning the fixed area (referring to Figure 20 B) in the distal portions 122 that framework 250 presses catheter body 120.When force compresses is scanned framework 250, force scan framework 250 along the first radial side 254 in weakenings office compression, cause scanning the continuum of framework 250 or spine 256 on by arrow 262 indicated directions crooked (referring to Figure 20 C).Fixed area (scanning the zone that framework 250 meets obstructions) can be the remote area on toolbox 102 or the catheter body 120.Yet, can be in the situation that the power that applies be crooked as long as scan framework 250, any zone all will be satisfied.

The interval of opening 252 and size can be selected to allow in the situation that to scan framework 250 distortion predefined curved.For example, can select opening 252 with the deflection of distal portions 122 plus or minus 90 degree of restricted conduit or the deflection of any angular bend, so that extra safety measure to be provided when the use system 100 in vascular.In addition, can in scanning framework 250, change interval between the adjacent apertures 252 and/or the size of opening.For example, the interval of opening 252 and/or large I increase or reduce along the length of scanning framework 250.In other modification, the interval of opening and large I oppositely change along the length of scanning framework 250.

Shown in modification in, the large I of scanning the opening 252 in the framework 250 increases in the direction away from first radial side 254 of scanning framework 250.Find that this structure can reduce to minimum with the interference of torsional axis (not shown).

In addition, the framework 250 that scans described herein can have any amount of feature, is connected to conduit 120 to help scanning framework 250.For example, scanned in those situations of framework 250 by super-elasticity or marmem structure, framework 250 can comprise one or more openings 253 that are arranged in sidewall, to increase the combination between super-elasticity/marmem parts and the regular metal shaft.

4. scan part (sweep member)

Tissue ablation system 100 when Figure 20 C shows the power of indicating in the direction that is applied to arrow 264.As noted above, can apply power 264 at near-end or handle 200 places of system 100 by the doctor.In some modification, can be by applying power with scanning part 270, scanning part 270 can move axially in catheter body 120.Scan part 270 and can comprise tubular structure or spline (spline) or the distribution with enough post intensity, scan framework 250 with compression and rotation.Move (typically, because toolbox 102 is fixed to catheter body 120) a long way off because prevent the far-end that scans framework, so it is crooked at spine 256 places on the direction of the first radial side 254 to scan framework.Go out as shown, the interval between the opening 252 can reduce simply, and this reduces to extend in 254 beginnings of the first radial side and to spine 256.This causes the hinged of cutting assembly 102, thereby the axis 111 of the cutting assembly axis runout with the near-end 258 that scans framework 250 that becomes is as indicated by angle A.As noted here, angle A is not limited to shown.On the contrary, angle can be scheduled to, and depending on provides any specific structure that scans framework 250 that is suitable for the angle of target vasculature or body cavity, and can change in the scope of plus or minus 90 degree or any predetermined angular bending.

In a modification, can be fabricated to hypodermic tube (hypo-type) structure (for example, by superelastic alloy or medical grade rustless steel structure) with scanning part 270 (be also referred to as and scan axle).Scan part 270 and can have the variable-angle of motility, to allow conduit 120 more flexible and more rigid at proximal part at distal portions.This permission improves the transmission that is guided through crooked ability of dissecting and improves the moment of torsion that produces at the near-end that installs.In other modification, scan part 270 and should not be easy to excess compression or prolongation, suppose that it must be sent to revolving force to scan framework 250.

In the hinged situation of cutting assembly 102, the doctor can further rotate shown in arrow 280 and scan part 270.When causing cutting assembly 102 about the axis camber motion of the near-end 258 that scans framework 250, the rotation of scanning part 270 causes scanning the rotation of framework 250 when hinged.The cutting assembly 102 that this motion causes having flexible length L passes the arc that has by the radiuses of 282 indications and moves.In some modification of device, scan framework 250 and scan part 270 and can rotate independently with catheter body 120.Yet, when scanning part 270 rotation, allow catheter body 120 with scanning framework 250 and scanning part 270 and rotate the resistance that can reduce to scan on the part 270.In this latter event, catheter body 120 and cutter housing 104 are with scanning framework 250 rotations.Yet, rotatable tool 108 (and torsional axis-not shown) still with scan framework 250 and rotate independently.

As noted above, greater than the arc of the diameter of conduit 120 (or toolbox 102) or this ability that circle is scanned cutting assembly 102, allow the doctor in the target location, to produce the remarkable larger opening of diameter than cutting assembly 102 itself.Such feature has been eliminated the needs with the independent cutting equipment exchange with larger cutting head with system 100.Such feature is not only saved processing (procedure) time, and system 100 can also produce the opening of variable size in body cavity.

Figure 20 C also shows the modification of scanning part 270 of any modification of the system 100 shown in can be applicable to here.In some cases, may expect that it will scan part 270 and scan framework 250 disengagings.In such a case, scanning part 270 can endwisely slip to break away from and scan framework 250.Yet, when scanning framework 250 and be re-engaged, scan part 270 and must also can rotate and scan framework 250.Therefore, scan framework 250 and scan part 270 and can comprise one or more keys and keyway (key-ways).Although illustrate show near-end 258 have keyway 266 and scan part 270 as key 272 scan framework 250,, allow in the scope that is configured in present disclosure of any type of rotary moving.

Figure 21 A shows the modification with the system 100 of scanning framework 250, scans framework 250 with the weakening part 268 with variable post intensity.In this modification, the post intensity of scanning framework 250 increases in the circumferential direction away from the first radial side 254.When scanning framework 250 deflection, the increase of post intensity prevents its radial distorted.Shown in modification in, scan in the opening 250 of framework 250 on scanning framework 250 and comprise a plurality of enhancing arms, rib or pillar 274, wherein, arm, rib or pillar 274 be configured to when scan framework 250 when crooked preferentially towards spine's 256 bendings.In this modification, comprise the second post intensity near the part that comprises arm, rib or pillar 274 of (but be spaced from) first radial side 254, but it is greater than the post intensity of radial side less than the post intensity of residue spine 256.The distortion of scanning framework 250 when equally, the post intensity of variation is intended to prevent deflection.

Figure 21 B shows another modification of scanning framework 250.In this modification, scan framework and comprise a plurality of rings 276, it separates to scan framework 250 interior generation openings 252.This ring can pass through separator, polymer coating or finally connect in carina area 256 with the ring 276 independent frameworks that are connected.As noted above, ring can be separated or changes its size, when framework 250 is scanned in compression, to realize the predefined curved of expectation.

Figure 21 C shows another modification of scanning framework 250, and it comprises and similarly woven, winding of vascular stent, braiding or cut network structure.Scan framework 250 structures and can comprise distribution or strip material, it has the enhancing part as spine 256.For example, can process the side that supporting structure scans framework 250 by coating, anchor clamps or any other device, to increase the post intensity of this part.Therefore, supporting structure scans this zone of framework 250 as the spine 256 of scanning framework 250.Although the spine 256 of Figure 21 B and Figure 21 C is shown as the bottom of scanning framework along corresponding, can the region of variation that framework manufactures provides aforesaid post intensity will be scanned.

Be appreciated that scanning framework can allow any structure of priority bending and rotation different from those have illustrated when placing conduit 120 interior.Can scan framework by various material manufacture, comprise that marmem, superelastic alloy, medical grade rustless steel or other polymeric material are as limiting examples.The material that scans framework 250 can be radiopaque, perhaps can change over radiopaque.In such a case, the doctor can be by before cutting and organizing, observing the bending scan framework 250 articulation degree of finder.

5. turn to and scan

Figure 22 A shows an example of the modification of excision system 100, and is aforesaid when scanning framework 250 and scanning part 270 when using, and excision system 100 is turned to.Under many conditions, it is useful making the distal portions 122 of system 100 and ability that cutting assembly 102 turns to.For example, when the abnormality of excision in the curved vessel organized as shown, should point to cutting assembly 102 towards the sidepiece of vascular 2, vascular 2 has more substantial stenotic material 4 with going out.Naturally, this orientation helps prevent the exposed wall/vascular 2 of incision, and cutting is concentrated on stenotic tissue 4.When in the sweep of vascular 2, were it not for steering capability, cutting assembly 102 will trend towards moving towards the extra curvature lateral deviation.Shown in Figure 22 A, turn to allow cutting assembly 102 inwardly to point to, to avoid the in addition cutting of blood vessel wall 2.

When the cutting clogged material, the ability that device 100 is turned to also allows to scan motion.Figure 22 B shows the rotation of cutting assembly 102.Shown in Figure 22 C, when cutting assembly 102 during with respect to the axis tilt of conduit, the rotation of deflector 102 produces scans motion.Be noted that rotation or the hinged rotation that also comprises conduit or hinged of cutting assembly 102, to allow cutting assembly with respect to the axis tilt of conduit.

Figure 22 D shows the front view along vessel axis, so that the motion of scanning that causes cutting assembly 102 scanning greater than the zone of the diameter of cutting assembly 102 to be shown.In most applications, when hinged, rotatable cutting assembly 102 is with at arc, wholecircle, or scans on the controlled paths of a plurality of circles.

The user of system 100 can be with the combination that moves axially of scanning motion and conduit 120 of cutting assembly 102, effectively to produce the opening of larger diameter on the length of blocking vascular.This is because system 100 is suitable for the chamber of " scanning " material, scanning feature allows system 100 to produce passage (namely in cavity, diameter), the diameter of cavity be conduit 120 diameter approximately 1 times to as high as approximately 4 times, this equals to produce cross-sectional area than the large passage up to 16 times of the cross-sectional area of conduit 120.The rotary-cut art system of existing with one heart operation with its capabilities limits in the cutting area of cavity being removed to its maximum.

By removing the diameter channels larger than the diameter of device for excising, clinically, system 100 produces relatively increase in the size of the cavity that is used for blood flow.Be suitable for that the diameter of cavity is increased the doubly scavenging system of (comparing with the diameter of conduit) can make the obtainable area of blood flow become and quadruple.This system be suitable for excising diameter range at about 1mm to the about vascular of 15mm, although less and larger-diameter vascular within the scope of the invention.In addition, system 100 is suitable for cutting assembly is crossed on the inner width (that is, about 10mm) of vascular.

For example, use formula (the π R of circular area ²), and using the conduit with 2mm diameter, the area of conduit is (3.14 * 1 ²)=3.14mm ²Now, use the cross-sectional area of the removing with 4mm diameter, the area of the cavity of removing is (3.14 * 2 ²)=12.56mm ², 4 times multiplying power of the cross-sectional area of conduit.Now, use the cross-sectional area of the removing with 8mm diameter, the area of the cavity of removing is (3.14 * 4 ²)=50.24mm ², 16 times multiplying power of the cross-sectional area of conduit.

Shown in Figure 22 E, conduit 120 has diameter D1.The ability that turns to and scan allows System Cleaning to have cavity greater than the diameter of section of conduit 120, comprises diameter D2 (twice of conduit diameter), D3 (conduit diameter three times) and D4 (conduit diameter four times).

When being placed on device on the seal wire (although not necessarily), be described for the movement combination that turns to and/or scan can carry out, for example, by in the proximal handle assembly 200 of system, using driving screw.The system of here describing on the other hand in, the angle that can be fixedly hinged is so that system 100 scans in even mode when rotating.

Figure 22 C also shows the modification of the excision system 100 with catheter body 120, wherein, when cutting assembly 102 when arc scans, first or the distal portions 122 of catheter body is such as rotation indicated in the arrow 280.The second portion 137 of conduit keeps static.Therefore, can connect two parts conduit to allow the relative motion between the cross section.Distal portions 122 and/or second portion 137 can comprise and scan framework 250 and/or scan part 270.

As mentioned above, it is static that catheter body 120 can keep, simultaneously, in scan framework 250 and scan part 270 rotations with moving cutter assembly 102 on the arc of intracavity or track.Replacedly, scanning framework 250 and scan part 270 can be with catheter body 120 rotation, but rotates independently with cutting assembly 102 and torsional axis 114.

Equally, scanning part 270 can be made of superelastic alloy, medical grade rustless steel, metal knitted structure, and metal knitted structure is clipped in the polymeric matrix of the material of polyethylene (PE), politef (PTFE), nylon and/or polyether block amide (PEBAX), polyurethane and/or silicone for example.Scanning part 270 also can be made by the wire coil of reverse-winding.Its far-end is crooked, and preferably by bearing highly crooked and keeping the material of its curved shape to make.Such material for example can comprise the polymer as PE, nylon, polyethers ether cave (PEEK), NiTi (Nitinol) or the spring steel of limiting examples.

As mentioned above, when designing catheter body 120 and/or scanning part 270, select to be used for the shape of bending, distortion and the expectation of axial strength characteristic, can improve the allomeric function of ablation catheter system 100.Except cutting assembly 102 being advanced and scans the improvement ability of cutting assembly with camber motion, suitable improved properties doctor's ability that conduit 120 is turned to.For example, the selection of the appropriate characteristics distal portions 122 that reduced conduit 120 rotates than the near-end on the handle 200 or control handle more than 202 or few probability.

These characteristics provide with the steering capability of conduit 120 can be initiatively and the passive system that turns to 100.Active steering can comprise to be made distal portions 122 bendings and rotates distal portions to turn to by the bending dissection.As described below, this allows the doctor with seal wire or without seal wire conduit 120 to be advanced through crooked the dissection, and will guide to the chamber sidewall towards front cutting assembly 102, to remove clogged material.For example, passive turning to can comprise advancing of conduit 120, until cutting assembly 102 contacts with knee in the vascular.The simple rotation that the inside radius that scans 250 pairs of bendings of framework is regulated the first radial side 254 scan framework (and regulate spine 256 to the outer radius of bending) allows flexible distal portions naturally or is preferentially crooked with vascular, and can continue to move forward conduit 120.

Figure 23 A to Figure 23 H shows conduit 120 by the movement of curved vessel 2, and cutting assembly 102 is turned to so that it is difficult to the treatment position near the interior corner of vessel branchings.Figure 23 A shows with Figure 23 B and enters vascular 2 until contact the conduit 120 of knee.Shown in Figure 23 B, not crooked spine 256 of scanning framework 250 is shown on the inside radius of vascular knee.

Figure 23 C and Figure 23 D show by turning to control to be positioned to the inside radius of knee with the first radial side 254 that will scan framework in handle 200 usefulness and rotating simply and scan passive the turning to that framework 250 is realized.This rotation of scanning framework allows distal portions and vascular naturally crooked, and, can continue to move forward conduit 120.Figure 23 E and Figure 23 F show the conduit 120 that moves to the next knee in the vascular 2, and repeat passive steering procedure and rotate inside radius to knee with the first radial side that will scan framework 250, allow flexible distal portions naturally crooked with vascular.

Thereby Figure 23 G and Figure 23 H show the conduit 120 of being removed material 4 by active steering with blood vessel wall in approaching.As can be seen, can move forward the control handle 202 on the handle 200, with the distal portions of deflectable catheter, and also rotatable grip 202 to be scanning flexible distal portions at pathological tissues 4, with its excision.

In another modification of the present invention, system 100 can improve the doctor and attempt the ability of seal wire 128 by the anatomical tissue (anatomy) of branch, bending or other obstruction.In the modification shown in Figure 24 A, when the doctor with seal wire 128 during by anatomical tissue, the anatomical tissue in the vascular 2 or the crooked character of obturator 4 may prevent advancing of the seal wire 128 that goes out as shown.In such a case, system of the present invention 100 allow doctors regain in the conduit 120 or just at the seal wire (shown in Figure 24 B) of the far-end of cutting assembly 102.Then, can make system 100 advance to branch point, or on bending position or obturator, advance, and hinged (shown in Figure 24 C), so so that the doctor can make seal wire 128 advance at obturator, acute angle bend pipe, or enter the branch of expectation.

As previously mentioned, can select the shape of housing 104 and window 106,107 position, thereby, when cutting assembly 102 during with the pathological tissues substantial registration, or engaging with the angle less than some critical angle of attack, it will cut effectively.Yet when pivoting with the angle greater than critical angle, cut edge or grinding element will not engage with pathological tissues, shown in Figure 24 D.This means, in larger deflection place, when the distal portions of cutting assembly 102 during near blood vessel wall, it automatically reduces its depth of cut, and, when surpassing critical angle, the most do not cut.For example, the tip far away of cutter 108 is blunt and does not cut.When cutting assembly 102 during to extrinsic deflection, blunt tip contact vascular, and make and keep contacting with blood vessel wall by subapical cut edge.In addition, seal wire also can be used as with cutting assembly 102 and prevents that the cut edge from arriving the buffer of blood vessel wall.Go out as shown, the part that seal wire extends from housing 104 will be with the bend radius of minimum.This allows seal wire near housing partly as buffer, and prevents that cutter 108 and window 106 from engaging with blood vessel wall.In some modification, can select to have the seal wire of Variable-Bend bilge radius, with the degree of protection by cutter 108 and tissue wall being separated provide different.

C. Handleset

Figure 25 A shows the exploded view of an embodiment that the system of being suitable for 100 provides the control handle 200 of operation control.Go out as shown, handle 200 can comprise handle seat (handlebase) part 201 and conduit base portion 204, and the two all can be snap-engagement or otherwise be bonded together, to form handle 200.Handle seat 201 and conduit base 204 can be offered the user, as aseptic, nonrecoverable and disposable device, provide with conduit 120 and cutting assembly 102.Two component type handles 200 allow the improved manufacturability of all parts, that is, and and handle seat 201 and conduit base 204, and be used for power supply (for example, supply unit 236) is separated with conduit base 204 with rotary apparatus 150.Should be appreciated that, handle 200 can be the single-piece handle, perhaps also more than two parts.

1. handle seat

Shown in Figure 25 A and Figure 25 B, handle seat 201 comprises the ergonomics handle, and is convenient to system 100 is operated control in function.First foundation parts (base piece) the 246 and second basic components 248 can engage with casing member together, and casing member comprises opening/closing device 234, supply unit 236, rotary apparatus 150 and the gear 206 that engages with rotary apparatus.Handle seat 201 can be made of for example polymeric matrix as the material of Merlon, acrylonitrile-butadiene-styrene (ABS) (ABS), polymethyl methacrylate (PMMA), polysulfones, polyethylene terephthalate (PET), high density polyethylene (HDPE) (HDPE), polyethylene (PE), nylon, polyether block amide (PEBAX), polyurethane and/or the silicone of limiting examples.Appreciable such as Figure 25 B, can engagement device (coupling means) 203 be set (for example at handle seat 201 and/or conduit base 204, snap-fastener, clip, glue, welding, heating and screw feature), and allow handle seat 201 freely to engage with instrument between the conduit base 204.

The control that opening/closing device 234 can be the rotation of cutter 108 provides various control to select, and comprises ON/OFF, acceleration and/or deceleration as limiting examples, and/or variable-ratio.Opening/closing device can be any various known controlling organization, comprises slide switch, button and/or potentiometer as limiting examples.

Expectation power supply 236 engages with opening/closing device 234 and rotary apparatus 150.Power supply 236 can comprise multiple known power supply, for example as not rechargeable battery, rechargeable battery and the capacitor of limiting examples.Desirably, power supply 236 all is suitable for power supply supply that rotating mechanism 150 is consistent in all operations condition, comprises non-loadedly to overload and stop state, and need not exceedingly consumable power source 236.Power supply also can have the operand power of scheduled volume, and for example as limiting examples: enough power is with continued operation system 100 in approximately 2 hours to approximately 3 hours processing procedure.

When energising, rotary apparatus 150 provides rotation for gear 206.Gear 206 and conduit base driven wheel 207 engagements (referring to Figure 30) that drive torsional axis 114.Rotating mechanism 150 (for example, electronic, pneumatic, fluid, gas, or other rotary system) rotating energy is passed to torsional axis 114, wherein torsional axis 114 is passed to cutter 108 with rotating energy.

The modification of system 100 can comprise that use all is positioned at the rotating mechanism 150 of handle 200, goes out as shown.In interchangeable modification, rotating mechanism 150 can be positioned at the outside of handle 200 and/or the outside of operative region (that is, in non-sterile zone), simultaneously, the part of system (for example, torsional axis 114) is extended in the outside of operative region, and engages with rotating mechanism 150.

Rotating mechanism 150 can be electric-motor drive unit.In a working example, use the electric-motor drive unit that moves and can produce up to the cutting speed of 25000RPM with 4.5 volts.Another embodiment of electric-motor drive unit comprises to be provided with the operation of 6 volts of rated voltages and with the motor of approximately 12000RPM operation with higher moment of torsion.This can realize by gear ratio was become 1: 1 from 3: 1.

In interchangeable embodiment, can be by controller to rotating mechanism 150 power supplies, controller changes speed and the moment of torsion that is supplied to conduit 120 and torsional axis 114, to optimize cutting efficiency or to utilize the variable velocity of the fixing flexible distal length of conduit 120 to make cutter 108 and/or automatically injection of cutting assembly 102, perhaps the length of the distal flexible part 122 by control conduit 120 provides further track control.Can control the length of flexible distal portions 122 (or predetermined portions), that is, comprise member 124 by inboard or the outside at conduit 120, or comprise that in the inboard of conduit and the outside member 124 regulates.But member 124 can comprise sheath, distribution or the seal wire of axial adjustment, for example, has the member 124 of the rigidity larger than the rigidity of flexible distal portions.See such as Figure 26 A, when sheath 24 was moved forward, the rigidity of its increase had reduced the motility of flexible distal portions 122.When at proximal retraction sheath 124, can increase with respect to the part that sheath 124 is retracted the length (referring to Figure 26 B) of flexible distal portions.

Can be by providing uneven element (that is, for example asymmetric cutter 108, housing 102 or counterbalance 123) to cause or strengthening track control (referring to Figure 26 C).When torsional axis 114 rotary cutter 108, asymmetric cutter (or housing) causes toolbox 102 in the upper rotation of curved path (that is, orbital path).Can increase the radius of this curved path by the length that increases adjustable flexibility distal portions 122, and on the contrary, can reduce by the length that reduces the adjustable flexibility distal portions arc rotary path.

Also may come operating system 100 with feedback control with the vascular safe mode, so that when near blood vessel wall, the cutting rate reduction.But this Negotiation speed controls to realize, perhaps realize by reduce the degree that cutting blade penetrates above housing window 106,107, and this can realize by the cutter of axially retracting in housing 104.Feedback variable can be by optics (infrared) or hyperacoustic sensor, perhaps by other sensor (for example, pressure, electrical impedance etc.), perhaps by monitoring the performance of rotary apparatus 150.Also can in security algorithm, use feedback variable, to stop cutter 108, for example, in the situation of torque overload.

2. conduit base

Appreciable such as Figure 27, conduit base 204 provides operation interface between the function of handle seat 201 and conduit 120 and cutting assembly 102.Conduit base 204 provides the extension of conduit 120, comprise the strain projection 234 of the far-end that is positioned at the conduit base, and provide the operation to conduit 120 to contact to turn to and scan toolbox (by scanning control handle 202, spring-loaded plunger 226 and calibration box 227), cutter rotation (by conduit base gear 207 and torsional axis 114), suction (by pump orifice 229), flushing (by rinse mouth 129) and seal wire (by guidewire lumen 130).Can provide bossing (male port) and recessed portion (female port), to determine concrete function.Appreciable such as Figure 27, also can engagement device 203 be set at conduit base 204, freely engage with instrument between the conduit base 204 to allow handle seat 201.

A. toolbox turns to and scans

Figure 27 to Figure 28 shows and scans control handle 202, spring-loaded plunger 226 and calibration box 227, and its combination allows the accurate calibration (that is, Position Control) of cutting assembly 102.Go out as shown, scan part 270 and torsional axis 114 and run through and scan control handle 202 and calibration box 227.Scan control handle 202 and calibration box 227 can with scan part 270 and engage, so that when control handle 202 is scanned in rotation, scan part 270 and calibration box 227 and as one man rotate, that is, scan the anglec of rotation and the anglec of rotation coupling of scanning part 270 and calibration box 227 of control handle 202.Be appreciated that to comprise extra actuating device, scan the rotary speed of control handle 202 or calibration box 227 with adjusting, or regulate the rotary speed of these two.

See such as Figure 28 A, calibration box 227 can comprise a plurality of calibration blocks (indexingstops) or obstacle (divots) 216.Although this modification of calibration box 227 comprises obstacle,, other form groove or the ripple (burr) of limiting examples (for example as) also can be used for the calibration purpose.Calibration block 216 can have two parts (dual) benefit.At first, when doctor's Spin Control handle 202, they allow the rotary index of increment.Owing to the bending of system 100, reversing and the axial strength characteristic allows between the far-end of system and the near-end seldom or do not have misalignment, so allow this increment calibration.The second advantage of calibration block 216 is, when making control handle 202 in the axial direction, the doctor moves forward with by scanning that part 270 is crooked or when turning to the distal portions 122 of ablation catheter system 100, it allows the axial calibration of increment the axial distal end direction is mobile.

Go out as shown, can form any amount of position 218,220,222,224 at calibration box 227.Shown in Figure 28 A, when control handle 202 rotation, spring-loaded plunger 226 can be the doctor tactile feedback is provided.In case doctor expectation is crooked or turn to excision system 100 by moving handle on axial direction 228 202, so, ideally, the doctor may feel that handle 202 (by spring-loaded plunger 226) enters the motion of the second stop location 220 and the 3rd stop location 222 (for example), shown in Figure 28 B.

Go out as shown, control handle 202 also can comprise leading mark 214, and it may be corresponding with the weakening part that scans framework 250 (not shown).Leading mark 214 also can be corresponding with a side of scanning framework 250, and this side is relative with the spine 256 of scanning framework.Because leading mark 214 may be by this way with scan frame alignment, so the doctor know, conduit 120 will with leading mark 214 corresponding directions on crooked.When cutting assembly 102 scanned in body cavity, this allowed when control handle 202 is scanned in doctor's rotation, and the doctor determines the orientation of cutting assembly 102 by the orientation of observing leading mark 214.Even may lose man-to-man relation, calibration handle 202 also can increase good vision control, with guiding distal portions 122 in limiting step or increment.This control can be useful because the doctor can the zone on limit in guiding cutter 108, working in the zone of needs excision, and because the excessive position that loses of moving is relative.When attempting in health to turn to cutting assembly 102 towards the treatment position of expectation, rotary-cut art or have the tissue ablation system that allows promotion and torsional strength and allow the doctor to feed back better and control.

As mentioned above, conduit base 204 comprise with scan that part 270 engages scan control handle 202.Scan control handle 202 and can make and scan part 270 and axially move forward, with the deflection of the distal portions 122 that causes scanning framework 250 and conduit 120.In addition, scanning control handle 202 can rotate independently with respect to the rotatable tool 108 in torsional axis 114 and the cutting assembly 102.

Shown in Figure 29 A, the distal movement of scanning control handle 202 makes scans part 270 and moves forward, the most advanced and sophisticated and cutting assembly 102 with deflectable catheter.Control degree of deflection by scanning the amount that control handle 202 advances.The axial advancement of scanning part 270 is scanned the restriction of the maximum deflection of framework 250.Be straight and not deflection in order to allow cutting assembly 102 and distal portions 122, can scan part 270 in proximal retraction by scanning control handle 202.This may cause removing axial force (some modification, can arrange and scan framework) from scanning framework 250 in straight structure.In other modification, scan control handle 202 with respect to scanning framework 250 and/or scan part 270 retraction catheter body, the most advanced and sophisticated and cutting assembly 102 with deflectable catheter.

Shown in Figure 29 B, the rotatable control handle 202 that scans is to scan cutting assembly 102 by the arc mode.Although also can scanning of cutting assembly 102 occur by manual operation (that is, the rotation of handle 200).The modification of handle 200 comprises can be optionally engaging with what activate automatic rotation with scanner's (that is, scanning control motor (not shown)) scans part 270.This may allow the doctor to scan toolbox 102 by steady, continuous, automatic mode, and need not to carry out any manual operation.

System of the present invention, apparatus and method allow the accurately rotation of definite cutting assembly 102 of doctor, because the rotation of the rotation of cutting assembly and control handle 202 is critically corresponding.Unless accurate corresponding can't the acquisition like this is catheter body 120 and/or scan part 270 and have enough bendings, reverse and the axial strength characteristic, as previously mentioned.Therefore, when these catheter body/scan part with have the handle 200 that scans control handle 202 when engaging, the other side of system 100 occurs, scanning control handle 202 can calibration and monitor the orientation of toolbox 102.Clearly, when distal portions 122 or cutting assembly 102 pairs of pathological tissues, obturator or illing tissues or when section runs into enough resistances, can lose this one-one relationship within it.Yet in such a case, even response may not be man-to-man, but system 100 still can resection organization and carries out its function.In any situation, keep approximate one-one relationship and minimum ability reduced in the proximal part of system 100 and the rotation misalignment between the distal portions allowing towards treatment position excision system 100 to be turned to.

B. cutter rotation and suction

Figure 30 shows the motor gear 206 of the rotation that is suitable for conduit base gear 207 (torsional axis gear), and wherein torsional axis 114 passes torsional axis gear 207 and engages.Transmit propeller (transfer propeller) 212 and can be attached to rigidly torsional axis 114, with the fragment of tissue 8 that will be extracted out from the attached aspiration container of conduit 120 suction.Torsional axis 114 can comprise one or more bearings (bearings) 210.Sealing 211 near bearing 210 prevents that the fragment of tissue of extracting out from spilling by bearing 210 at near-end.

As previously mentioned, torsional axis 114 can have transmission parts or helicla flute 118 on its overall diameter and/or in center guidewire lumen 130.In the process that treatment is carried out, 206 rotations of motor 150 driven wheels.This causes driving shaft 208, transmission propeller 212, torsional axis 114 all to rotate in identical direction of rotation with cutter 108.Therefore, toolbox 102 cuts speckle 8 effectively, and can further speckle be worn into less sheet, and then, driving fragment 8 returns the helicla flute 118 on the torsional axis 114.The helicla flute 118 of rotation is fragment wraparound conduit base 204, then, by transmitting propeller 212 fragment is sent to aspiration container.For example, propeller 212 can adopt the form of the fan blade of screw or a series of angle circumferential arrangement.Cutter 108 can be with the approximately extremely approximately speed of the scope of 25000rpm rotation of 8000rpm, although higher and lower speed within the scope of the invention.Interchangeable design will have the aspiration container that is embedded in catheter hub (catheter hub) 204 and/or the handle seat 201.

System 100 also can comprise vacuum source or pump 152, to help to discharge the fragment that operation was produced by device.Can use any amount of pump or vacuum source with system.For example, peristaltic pump can be used to from the system drive material, and makes it enter waste canister.Figure 25 A also shows the system 100 that engages with fluid source 154.The same with rotating mechanism 150, vacuum source and/or fluid source can engage with system 100, for example, and at handle 200 places, from inside or the outside of operative region.

C. flushing

Figure 27 shows as having the conduit base 204 of rinse mouth (flush port) 129.It is a kind of for fluid (for example, the normal saline of heparinization or any other medicines) being injected catheter body 120 and conduit base 204 with the device in the space between the part that stops blood and fragment of tissue blocking device that rinse mouth 129 provides.Rinse mouth 129 also can help the moving parts in the lubrication conduit 120.The fluid path of an expectation is along catheter body 120 and the length of scanning the conduit 120 in the space between the part 270.Can introduce medicine or fluid by rinse mouth 129, to flow out near the one or more openings 131 distal portions 122 or the cutting assembly 102.Then, near the medicine of going out cutting assembly 102 can inject blood vessel wall.For example, use thrombosis depressant, narrow depressant and/or antibiotic medicine, can after thrombectomy or the treatment of speckle rotary-cut art, help prevent restenosis.Possible medicine for example can comprise rapamycin (rapamycin) and the analog (for example, everolimus, biology are not taken charge of (biolimus) and sirolimus) as limiting examples; The M-prednisolone; Interferon y-lb; Leflunomide; Mycophenolic acid; Mizoribine; Ciclosporin; Tranilast; Biorest; Tacrolimus; Taxius; Clopidogrel; Rapamycin; TAXOL; Botox (botox); Lydicane; Dimension A chemical compound; Glycosamine; Chondroitin sulfate (chondroitin sulfate); Or geldanamycin analog 17-AAG or 17-DMAG.

Other bioactive materials of wide region can be sent by system 100.Other example comprises: heparin, covalency heparin or another thrombin inhibitor, hirudin, HIRULOG, argatroban (argatroban), D-phenyl alanyl-L-gather-L-arginyl chloromethyl ketone or another antithrombotic agents, or its mixture; Urokinase, streptokinase, Tissue Blood plasminogen activator protein (tissue plasminogen activator) or another thrombolytic agent or its mixture; Fibrinolytic agent, vasospasm inhibitor, calcium channel blocker, nitrate, nitric oxide, nitric oxide promoter or another vasodilator; The Hytrin hytrin Or other hypotensive agent; Antibacterial or antibiotic; The inhibitor of aspirin, ticlopidine, glycoprotein iib/iiia inhibitor or another surface glycoprotein receptor or another anti-platelet agents; Colchicine or another antimitotic agent or another microtubule inhibitors, dimethyl sulfoxine (DMSO), biostearin or another secretion inhibitor agent; Cytochalasin (cytochalasin) or another actin inhibitor; Or reinvent inhibitor; DNA (deoxyribonucleic acid), antisense nucleotide or another reagent of interfering for molecular genetic; Methotrexate or another antimetabolite or antiproliferative; TAMOXIFEN CITRATE (tamoxifen citrate, tamoxifen citrate), TAXOL (Taxol)

Or derivatives thereof or other anticancer chemotherapy agent; Dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative or another anti-inflammatory type sterin or non-steroidal anti-inflammatory drug; Cyclosporin or another immunosuppressant; The long factor antibody of trapidal (PDGF antagonist), angiopeptin (growth hormone antagonist), angiogenin, somatomedin or antibiosis or another growth factor antagonist; Dopamine, bromocriptine methanesulfonate (bromocriptine mesylate), pergolide mesylate or another dopamine agonist; ⁶⁰Co (5.3 year half-life), ¹⁹²Ir (73.8 days), ³²P (14.3 days), ¹¹¹In (68 hours), ⁹⁰Y (64 hours), ^99mTc (6 hours) or another radiotherapy dose; Contain iodine compound, baric mixture, gold, tantalum, platinum, tungsten or another heavy metal as radiopaque medium; Peptide, protein, enzyme, extracellular matrix components, cell component or another biological preparation; The how general riel of Kapp, enalapril (enalapril) or another Angiotensin-Converting (ACE) inhibitor; Ascorbic acid, alpha tocopherol superoxide dismutase, deferoxamine, 21-aminosteroid (lasaroid) or another free radical scavenger, iron chelating agent or antioxidant; Any above-mentioned ¹⁴C-, ³H-, ¹³¹I-, ²¹P-or ³⁵S-labelled with radioisotope form or other labelled with radioisotope form; Estrogen or another gonadal hormone; AZT or other anti-polymerase (antipolymeras); Acycloguanosine (purine biosynthesis nucleoside analog), famciclovir (famciclovir), rimantadine hydrochloride, ganciclovir sodium (ganciclovirsodium), ritonavir, indinavir or other antiviral agent; 5-ALA, meta-tetrahydroxy phenyl chlorin, ten hexafluoro ZnPcs (hexadecafluoro zincphthalocyanine), tetramethyl hemoporphyrin, rhodamine or other photodynamic therapy agent; Monoclonal antibody or other antibody target therapeutic agent of the norepinephrine enzyme dopamine β-hydroxylase of opposing ETA and the IgG2 κ antibody that works with A431 squamous epithelium cancerous cell, opposing and saporin (saporin) conjugation; Gene therapeutic agents; And enalapril and other medicines precursor; Proscar (Proscar)

Hytrin

Or other is used for the treatment of the reagent of benign prostatic hyperplasia (BHP) or the mixture of any these medicines; And various forms of submucous layer of small intestine (SIS).

III. other system features

A. energy is sent

The structure of cutting assembly 102 can provide the energy of other pattern to send.For example, when system 100 in vascular regions during resection organization, (for example, lung biopsy and excision) can occur excessively bleeding.Therefore, can energy be delivered to the target location by conduction toolbox (that is, for example housing 104 and/or stage property 108).Acoustic energy (ultrasound wave), electric energy (radio-frequency current), perhaps in addition microwave can be used for this purpose.These energy sources of sending by toolbox 102 also can be used to make tissue (collagen) degeneration, shrinkage tissue, or ablation tissue.Alternatively, if use seal wire, seal wire can be removed and replace with cable, send and/or transmit radiation therapy, the treatment that comprises independently or make up to be used for the UV energy.

B. distal portions is visual

Figure 31 A and Figure 31 B show the modification of scanning framework 250 with visualization feature 284, when in the non-intruding imaging (for example, when fluoroscopy) descending finder, visualization feature 284 allows doctors to determine hinged orientation and the direction of cutting assembly 102.Figure 30 A shows a modification of visualization feature 284, visualization feature 284 be scan framework 250 perpendicular to recess (notch) or opening 284 on the side of the direction of framework bending.In an example, 256 one-tenth 90 visual marker is set with spending with respect to spine.Although feature 284 is illustrated on the right side of scanning framework 250, can use any side, as long as the position of feature 284 and orientation convey to the doctor by orientation and the direction that non-invasive imaging will scan the bending of framework 250.

Figure 31 B shows another modification of the alignment features 284 that comprises mark substance (for example as the radiopaque additive of limiting examples and/or be deposited on the radiopaque metal of the height that scans on the framework 250).In any situation, when observing in non-intruding imaging form, visualization feature 284 must provide enough and contrast framework 250.For example, these visualization devices also can comprise such as recess, opening, draw ring (tab), extension or sedimental layout.

Go out as shown, when the spine 256 of framework 250 was directly adjacent to the doctor, visualization feature 284 was on the right-hand side that scans framework 250.In this position, hinged (the appearing on the direction away from spine) of scanning framework causes scanning framework 250 deflections and leaves the doctor.Therefore, when the visual marker 284 on doctor's finder right side, the doctor will know, scan framework 250 and bending away from the doctor will occur directly.Clearly, the doctor the present invention includes any amount of visualization feature or the such layout of feature on the other parts of any part of scanning framework 250 or distal portions (cross section) 122, as long as can determine to scan orientation and the direction of the bending of framework 250 by observing visual marker 284.

C. rinse solution

Solution is injected (for example, flushing) may be expected to targeted treatment site.The cooling normal saline that injects can prevent heating blood and other tissue, and this has reduced the probability of thrombosis or other tissue injury.Heparinized saline also can be prevented tampon, and dilute blood maximizes pumping efficiency with help.The flushing also can comprise thrombosis depressant, narrow depressant or antibiotic medicine, for example listed above those.This may help prevent restenosis, and can cause better long-term open.Irrigation (flush) can comprise anesthetics or long-acting level and smooth amyotonia medicine, with the at once elastical retraction (acute recoil) that prevents vascular.Figure 32 A to Figure 32 C shows the modification of rinse-system 100.Can pass through the side chamber 132 (Figure 32 B) in guidewire lumen 130 (Figure 32 A), the catheter body 120, and/or the side mouth in the seal wire 128 (side port, sideport) 127 (Figure 32 C) injection irrigation.

Irrigation can flow out from the port of the far-end of cutter 108, points to irrigation so that suction at near-end.Replacedly, by the gradually irrigation agent of far-end of the cutter housing 104 on circular surface, can pass through wall attachment effect (Coanda effect, Coanda effect) and guide backward liquid stream.Can carry the restenosis inhibitor by the microcapsule with tissue adhesive or Velcro shape (velcro-like) feature from the teeth outwards, to be bonded on the interior vessel surface, so that medicine adheres to treatment position, and provide the time that absorbs again or dissolve control by coating to discharge, with the further efficient of improving.Such Velcro shape feature can be constructed to have the nanoscale structures of being made by the organic or inorganic material.Reduce the volume of exotic and remaining tissue and extracellular matrix are exposed in medicine, stimulation or the sensor, can be so that any these technology be more effective.

The another kind of mode of injecting fluid is, provides pressure fluid (for example, gravity and/or carry out pressure with venous transfusion bag and carry) at the proximal part of guidewire lumen 130.For this reason, the hemostatic seal that has a side branch is useful; Y shape adapter (tuohy-borst adapters) is an example realizing the device of this purpose.

The relative quantity balance of injection that will be relative with the fluid volume of suction allows the control vascular diameter; Aspirate more the multithread body vascular of will finding time than perfusion gradually, shrink its diameter, and allow with the diameter cutting pathological tissues larger than rotary-cut art conduit.For some open type Tool Design of using suction, this has become problem, the tremulous pulse around the cutter knife is found time and makes its fracture because gather the required strong suction of embolic particles.This also is performance issue, because cutter can get into a difficult position owing to too high torque loads, and cutter can easily make the vascular perforation.These problems have been eliminated in toolbox 102 designs described herein, and further needs strong suction still less provides wider span of control to become effectively to the user.

D. fast exchange

Figure 33 shows and is constructed to the fast modification of the system 100 of exchange.Go out as shown, in order at seal wire 128 device 100 to be advanced, system 100 comprises jitty, cavity, or other track (track) 136.Yet track 136 does not extend along the total length of conduit 120.In addition, can be in the extention of far-end 134 positioning tracks 136 of conduit 120, with centering seal wire 128.

This feature is by only keeping seal wire static and at seal wire pulling or moving system 100 and the quick disengaging of permission system 100 and seal wire 128.A benefit of such feature is that seal wire 128 can remain close to treatment position when breaking away from system 100.Therefore, the surgeon can advance attachment device at seal wire 128, and in mode fast it is moved to described position.This structure allows conduit 120 to separate with seal wire 128 rapidly, and allows to introduce another conduit at seal wire, because most of seal wire is all in the outside of conduit.

E. on distribution

As shown in figure 34, cutting assembly 120 can be improved with respect to control, contact and the location of body cavity or vascular 2 in seal wire 128 centering in the tip of cutting assembly 102.In order to realize this purpose, cutting assembly 102 can have the center cavity 130 that holds seal wire 128.The modification of system 100 comprises center guidewire lumen 130, and its length at conduit 120 is extended, by all or part central module (comprising torsional axis 114, cutter 108 and handle 200).As noted above, seal wire 128 can be fixed to other on-rotatably moving part of housing 104 or cutting assembly 102.In such a case, seal wire 128 is short section preferably, and it helps guiding device by the obstruction part of body cavity.Yet system 100 also can operate without seal wire, and is because distal portions 122 can turn to, similar with seal wire.

F. combined therapy

Device of the present invention, system and method also can other structure in being placed on body cavity use.For example, as shown in figure 34, a kind of method of protecting vascular and allowing maximum speckle volume to reduce is to arrange protection structure (for example, support, expansible thin coil or expansible net 182) in pathological tissues.When extending after this structure is being arranged, thin coil or pillar promote speckle radially outwardly, until it becomes basically concordant with blood vessel wall.This expansion of thin member needs the minimum of speckle volume to shift, and the barotrauma (windage) that produces in balloon angioplasty or the air bag expansion stent delivery is reduced to minimum.In case protection structure 182 expand fully, can carry out the rotary-cut art cutting away the interior speckle 4 of vascular 2, thereby open the chamber.Protect blood vessel wall by expansion structure 182, because structural member (coil or pillar) stops cutting by rotary-cut art cutter 108, and be arranged in such a way: its can not retraction cutter housing 104 in (thereby being caught by cutter 108).Also may regulate the angle of the window 106 on the protection cutter housing 104, thereby, itself and pillar or coil misalignment.In coil or pillar design, in the cutter housing design, perhaps in the design of these two, can consider the adjusting to orientation.

In addition, guard member 182 can be relative flexibility, and has small size (profile) (that is, thin element), so that it can be used as support and stays the original place.Because it is open that the support in this situation mainly relies on the rotary-cut art to recover cavity, so it can be designed to apply at that time much smaller radial force when arranging.This allows to use wider material, and some of them may not have high Rigidity and strength the same as bioresorbable polymer and metal alloy.And this allows more resilient design, is subject to mechanical force in peripheral arterial.It also minimizes flow disruption, so that the hematodinamics complication is minimized, for example, with the relative little relevant thrombosis that flows of in periphery, finding.Also may before placing protection structure 182, carry out the rotary-cut art, no matter whether after placing this structure, carry out the rotary-cut art.

As mentioned above, it may be favourable engaging the rotary-cut art by erection bracket.By removal lesion tissue, need less radial force further to open tremulous pulse and keep cavity diameter.The amount of capable of regulating excision as one man shows well with the mechanical property with selected support 182.For the support that larger amount of expansion and radial force is provided, need relatively little rotary-cut art to obtain gratifying result.

Interchangeable Therapeutic Method (approach) is removal lesion tissue basically, and this is placed as the intrinsic mechanical condition of periphery anatomical tissue with allowing and the support optimized.In essence, support can rest on itself on the blood vessel wall, and the opening of the radial force of appropriateness with the maintenance cavity is provided.Support can be biological resorbent and/or medicament elution, as limiting examples, can in cycle above to as high as 12 weeks a couple of days again absorption or eluting occur.The cycle in 4 to 12 weeks and the time course of reconstruct are mated very much, and as turning back to of in the typical wound healing reaction, seeing stable, especially in the known reconstruct time course of stent in the treatment (procedures) tremulous pulse afterwards.

In addition, can optimize bracket geometry, by in blood flow, causing whirlpool thrombosis is reduced to minimum.This has and will cause the mobile effect that minimizes or eliminate thrombotic stagnation or recirculation.Near-end (upstream) spiral structure partly to limited bracket 182 can be realized this purpose.It may also help guarantees directly can not produce zone any stagnation or recirculation flowing of rack far end, and whirlpool also is a kind of mode that prevents this phenomenon.

Can further system 100 be configured to have air bag 138 or other mechanism near cutter, to be used for additional angioplasty, support and/or drug delivery (for example, referring to Figure 40 A and Figure 40 B).On the whole, system 100 can be at first with mechanism 138 (referring to Figure 40 A) the excision vascular that does not launch, then development mechanism, the air bag 138 of medicine coating for example, because compare with the drug delivery in the unfinished vascular, the air bag drug delivery may be more equal even effective drug delivery (referring to Figure 40 B).System 100 also can come delivering drugs treatment (pharmacotherapy) by guidewire lumen 130.For example, can come delivery of fluids by the chamber, and wherein cutting assembly 102 turns to towards speckle and/or blood vessel wall, the jet of Drug therapy can be delivered to the target location.

System 100 may be configured to send Self-expanded stent alternatively.This feature provides users with the convenient, and has guaranteed better to carry out the additional treatment of the target location of rotary-cut art.

G. other system features

In the device that other parts can here be described in conjunction with (comprising), the system and method.For example, can expect to make sensor and/or changer 144 in conjunction with (comprising) in the distal portions 122 of catheter body 120 and/or cutting assembly 102 and/or on it, to distinguish (sign) speckle and/or contact speckle and wall thickness and vascular diameter, to be used for the treatment of plan (referring to Figure 41 A and Figure 41 B).Also may expect the progress of changer 144 expression excisions or the degree of cutter 108 close blood vessel wall.For example, but be installed in pressure transducer 144 sensings on conduit housing 104 or the cutter 108 in the increase that housing is pressed against the contact force that occurs in the situation of blood vessel wall.Temperature sensor 144 can be used to detect the easy damaged speckle.Ultrasonic converter 144 can be used to cavity region, speckle thickness or volume, and wall thickness carries out imaging.Electrode 144 can be used to the impedance of the tissue of sensing contact, and this allows distinguishing between plaque type and the blood vessel wall type.Electrode also can be used to the transferring energy pulse, for example, with the assessment innervation, or stimulates or the prevention smooth muscle, or characterizes speckle (composition, thickness etc.).For example, can produce of short duration spasm so that vascular has less diameter, this is so that be easier to its excision, and then electricity consumption or medication are overturn it.Also can transmit electric energy, to improve sending of medicine or biological preparation by cause cell membrane to open (electroporation) in response to electricity irritation.A kind of method that characterizes with electrical measurement is electrical impedance tomography.

Optical coherence tomography (OCT) can be used to carry out the measurement of speckle and wall thickness.See such as Figure 42, for example, can provide OCT device 146 with toolbox 102.Also OCT device 146 can be incorporated in the target area by guidewire lumen 130.The distal portions 122 that can turn to not only allows the controlled observation of the core of vascular, but and oppose side wall carry out imaging.With the front cutting assembly 102 of OCT device 146 combinations allow before the excision vascular, among and afterwards to the target treatment area domain imaging.Can reduce with simple normal saline flushing the absorption of the light wave in the blood, to improve the imaging of viewing area.

IV. lower limb are dissected

Figure 36 shows the tremulous pulse of pelvis and lower limb.As previously mentioned, device, system and method all are very suitable for using in this outer regions.The aorta that extends from pelvis is iliac artery, wherein internal iliac artery with most of blood supply to pelvis internal organs (pelvic viscera) and pelvis wall.

External iliac artery is by larger pelvis (false pelvis) bifurcated, and the section of becoming a shareholder that goes forward side by side (thigh) becomes right femoral artery and left femoral artery.Article two, femoral artery is sent to genitals and stomach wall with top branch.Nearly surperficial femoral artery just is branched into deep femoral artery (being also referred to as dark femoral artery) at once after producing.Dark tremulous pulse is advanced downwards along femur, than femoral artery from femur more close to, between pectineus and adductor longus m., spread.

Femoral artery passes Hunters canal (adductor canal), and faces down after kneed and extend inboard and the rear side of femur, very flexible zone, and herein, it becomes into the popliteal tremulous pulse.， popliteal tremulous pulse spreads downwards at the rear side of shank between knee and ankle, and is called posterior tibial artery.Below knee, peroneal artery provides structure from the ossa tibiale posterius bifurcated with the inboard at fibula and calcaneus (all not shown).In diseased section, anterior tibial artery Cong popliteal is partly pitched, and spreads along the front surface of shank.It becomes dorsal artery of foot at ankle.At the ankle place, ossa tibiale posterius is divided into medial plantar artery and lateral plantar artery.Lateral plantar artery and dorsal artery of foot form the arch of foot together.From this bow section, refer to that tremulous pulse is to the toes blood supply.

A. the representative applications of rotary-cut art system

Described excision system 100 is so that possibility single insertion conduit 120 so that the treatment of occluding body lumens to be provided, comprises that the tremulous pulse from lower limb is removed pathological tissues, and the single of conduit 120 inserts and comprises the material that removal is excised.Excision system 100 is suitable for carrying out excision in vascular in a big way, comprises the tremulous pulse in upper limb and the lower limb, for illustrational purpose will be described its representative example.

In the tremulous pulse structure in a big way that system 100 can be used for existing in the shank, comprise crookedly with straight, and can be used in short pulse pipe and the long pulse pipe, i.e. 20cm or longer.System 100 will be very suitable for more than knee until femoral artery,common uses, although will understand, can near using this system in the tremulous pulse of femoral artery,common.This system also is very suitable for using in the tremulous pulse below knee, and can be all local uses the down to ankle and/or foot.

Can have vessel size in a big way in the shank, all these can be processed by system 100.The representative diameter of conduit 120 to the scope of about 3.0mm, provides the target location that approaches in a big way at about 1.0mm.For example, the scope of the diameter of femoral artery,common at about 6mm to approximately between the 7mm; The scope of femoral artery,superficial at about 4mm to approximately between the 7mm; The scope of popliteal tremulous pulse at about 3mm to approximately between the 5mm; And the scope of tibial artery at about 2mm to approximately between the 4mm.

Find deep femoral artery and femoral artery,common than being used for erection bracket and/or little with the expectation area of air bag, for example, because the bypass graft of this area reply femoral artery keeps available.Provide a kind of good solution for excision for the device, the system and method that carry out the rotary-cut art in these zones.

The selection that exists target location multiple and shank inside to contact.Contact based on the target area with expectation, have various possible active lengths for system 100.For example, can have four size Selection: 1) homonymy (same side) contact and down to the position of knee top; 2) with side contacts and down to the position below the knee; 3) offside (opposite side) contacts and crosses and down to the position of knee top; And 4) to side contacts and cross and down to the position of knee below.Size Selection considered and the contacting of various dissection contact points (entrance), for example, and femoral artery, brachial artery etc.

The scope of the typical active length of system 100 for the approximately 110cm that is used for the homonymy method to about 130cm (referring to Figure 37), and the approximately 130cm that is used for the offside method may extend below knee to about 150cm (referring to Figure 38).To side contacts may be the expectation and/or necessary because conductor may block area for treatment (position).

V. the operation instruction of this system

Operation instruction 404 can instruct the use of passing through contact position in the peripheral blood vessel based on the system 100 of conduit, for example, in femoral artery, has alternatively the help of image guided (imageguidance).Image guidedly include but not limited to fluoroscopy, ultrasound wave, magnetic resonance, computed tomography imaging, optical coherence tomography, or their combination.

Can cost than the treatment of time still less of existing device for excising in use system 100, for example, Resection in Treatment can carry out within 45 minutes or shorter time.In addition, need repeatedly conduit to change with existing device for excising and compare, only need the single of system 100 to insert to treat (that is, not having conduit to change).This be because, system 100 is suitable for " scanning " material chamber, scan feature and allow individual system 100 in cavity (chamber), to form passage, the diameter of this cavity be conduit 120 diameter approximately 1 times to as high as approximately 4 times.This system be suitable for excising diameter range at about 1mm to the about vascular of 10mm, although the vascular of less and larger diameter also within the scope of the invention.

Before use, the clinician identifies specific vascular regions, will apply the TA that uses rotary-cut art system 100 to this zone.Preparing this position contacts to carry out vascular with tremulous pulse to be treated.Can from aseptic packaging, take out excision system 100.The distal portions 122 of system 100 is inserted in the tremulous pulse, and makes it move forward to the target location.Also can in the process of this treatment stage, use seal wire.The steering capability of system 100 can be used to help the surgeon that system is turned to, and makes it arrive the target location by curved vessel.In case cutting assembly is in the target location, the surgeon comes 100 power supplies to system by pressing or activate opening/closing device 234.The surgeon can be only with the operation of hands control system 100 on ergonomics handle 200.In the situation of RPM rotary cutter 108 with expectation, image guided lower, the surgeon moves forward conduit 120 at far-end at leisure, with cutting and remove speckle.The motion of scanning that the surgeon can utilize the ability of scanning of system 100 to produce cutting assembly 102 to scan and to cut pathological tissues at curved path, is removed thereby produce diameter in 4 times the vascular of diameter that may be conduit 120.When producing cutting, system at first uses the first cut edge 112 incision of matter, then further incision of matter is cut into or wears into less sheet, so that the length by conduit 120, transport by conduit base 204, and export container to from pump orifice 209.

Depend on the treatment of expectation, system 100 can be used for foregoing combined therapy.For example, if use seal wire, then can remove seal wire and select replacement with other treatment, for example, the UV radiation.Perhaps, available foregoing rinse-system is the infusion of medicine target location, this may before the Resection in Treatment, among or carry out afterwards.

After vascular has been removed pathological tissues, surgeon's shutdown system, and fetch conduit from vascular at leisure.Clean and the wrapping in-position.Can be at each hospital or the upper arrangement system 100 of facility guiding figure (facility guidelines).

In addition or interchangeable explanation various processing and the use of this system can be described.For example, operation instruction can be described the use of conduit, illustrates to comprise following operation: near the position that conduit tube component is incorporated in the blood vessel and will organizes cutting assembly to be positioned to need cutting tissue or its; Manipulation of tissue is removed assembly with the tissue in the excision blood vessel; In the vascular of at least twice of the diameter of removing assembly for tissue, produce the diameter of organizing of removing; And remove the tissue remove.

The operation instruction of describing the use of conduit also can comprise following operation: be incorporated into conduit tube component in the blood vessel and the position that will organize cutting assembly to be positioned to need cutting tissue or its near; Thereby the distal portions of operational deflection control device deflectable catheter; Thereby and the distal portions of operation rotating control assembly rotary guide pipe on curved path.

Other explanation of describing the operation of conduit can comprise following operation: be incorporated into conduit tube component in the blood vessel and the position that will organize cutting assembly to be positioned to need cutting tissue or its near; Scan part at the direction upper deflecting curved frames of the first radial side of curved frames by moving in the proximal end of conduit or near it, thereby cause organizing cutting assembly at the direction upper deflecting of the first radial side; The torsional axis that will run through conduit and engage with at least one rotatable tool is rotated; Scan part with torsional axis is mobile independently, with the rotoflector framework and cause organizing cutting assembly near-end axis with respect to curved frames on curved path to scan; And removal clogged material.

The other explanation of describing the operation of conduit can comprise following operation: the conduit that is dimensioned and is configured to be incorporated in the blood vessel is provided, this conduit comprises near the far-end of conduit or its organizes cutting assembly, and this tissue cutting assembly comprises for the rotatable tool from the vessel resection tissue; The control handle that engages with conduit tube component is provided, and this control handle comprises the transfer of organizing cutting assembly be used to turning to; Conduit is incorporated in the iliac artery; Make conduit enter in the femoral artery, deep femoral artery, Hunters canal tremulous pulse, popliteal tremulous pulse, tibial artery, peroneal artery, dorsal artery of foot, medial plantar artery, lateral plantar artery or refer to tremulous pulse; With organize cutting assembly to be positioned at tremulous pulse, popliteal tremulous pulse, tibial artery, peroneal artery, dorsal artery of foot, medial plantar artery, lateral plantar artery in femoral artery, deep femoral artery, the Hunters canal refer to target location in the tremulous pulse or its near; Operate transfer by the first power is applied to transfer, this first power causes the distal portions of conduit at the radial direction upper deflecting; Operate transfer by the second power is applied to transfer, this second power causes the distal portions of conduit when at radial direction upper deflecting distal portions to rotate at curved path; Make distal end of catheter advance to scan the target location, thus allow rotatable tool on curved path from target location resection organization; And remove the tissue of excision from the target location, thereby treatment blood vessel.

VI. system tool bag (system tool external member, system kit)

As shown in figure 39, system 100 and the device of just having described can be merged, in multi-purpose tool bag (multiple piece functional kit) 400, to use.It will be appreciated that, system 100 and device may not be shown to scale.

Tool kit 400 can adopt various forms.In the embodiment shown, tool kit 400 comprises independent packing, the assembly that this packing comprises is aseptic, wrapped, open.Tool kit 400 can comprise the inner pallet (interior tray) 402 of support (maintenance) content, and this inner pallet 402 is by for example opening cardboard (die cut cardboard), plastic sheet, or the hot forming plastic material is made.Tool kit 400 also preferably includes explanation or the description (guidance) 404 of carrying out the treatment of aforesaid expectation about the content of tool using bag 400.

Tool kit 400 provides the critical piece of aforesaid excision system 100, comprises cutting assembly 102, conduit 120 and handle 200, and it is assembled together and prepares and uses.In one embodiment, handle seat (handle base) 201 can not engage with conduit base 204.Remaining parts can be the optional accessories that uses in the layout of system 100, for example, and traditional vascular contact sleeve 406; Traditional (for example, 0.014 inch) seal wire 128; And comprise for the normal saline of the heparinization of catheters irrigation and be used for the sack of the contrast medium (contrast agent) of angiography 408.

Certainly, operation instruction 404 can change.Operation instruction 404 can physically be present in the tool kit, but also can provide separately.Can be in independent instruction manual imbody operation instruction 404, or in video or audio recording imbody.Also can obtain operation instruction 404 by internet webpage.

It only is the illustrative of the principles of the inventions that foregoing is considered to.In addition, because for a person skilled in the art, many modifications and change will appear easily, so, do not expect the present invention is limited to shown and described accurate structure and operation.Although described preferred embodiment,, can change details not deviating from the situation of the present invention that is limited by claims.

Claims (9)

1. system comprises:

Conduit has tissue and removes assembly near the distal portion office of described conduit or its, have the deflection section in the distal portion office of described conduit, and described deflection section has length L, straight axis S and clinoid D,

Deflection piece, be connected to described conduit, and be suitable for operating the described deflection section of described conduit, so that the length L of described deflection section is deflected to described clinoid D from described straight axis S, with angulation A between described straight axis S and described clinoid D, the scope of described angle is between 0 degree is spent to 90; And

Control handle, be connected to conduit, described control handle comprises deflection control device and rotating control assembly, described deflection control device is suitable for controlling the deflection of the radially offset direction of described deflection section, and described rotating control assembly is suitable in the described distal portions of the described conduit of deflection the described distal portions at the described conduit of curved path rotation.

2. system according to claim 1:

Wherein, described deflection control device and described rotating control assembly comprise deflection and Spin Control handle, and it is suitable for the described distal portions of the described conduit of deflection and rotates the described distal portions of described conduit at curved path in the described distal portions of the described conduit of deflection.

3. system according to claim 2:

Wherein, described deflection and Spin Control handle are suitable for by applying the described distal portions that the first power is come the described conduit of deflection to described deflection and Spin Control handle, and

Described deflection and Spin Control handle are suitable for by applying the second power to described deflection and Spin Control handle, in the described distal portions of the described conduit of deflection, at the described distal portions of the described conduit of curved path rotation.

4. system according to claim 1, wherein:

Described tissue is removed assembly and is comprised for the rotatable tool from the vessel resection tissue, wherein,

Described control handle comprises be used to the rotary apparatus that rotates described rotatable tool; Be used to described rotary apparatus that the power set of power are provided, described rotary apparatus is suitable for rotating described rotatable tool; And the opening/closing device that is used for controlling the power that is supplied to described rotary apparatus, and

Torsional axis extends to described rotatable tool from described rotary apparatus, and described torsional axis comprises aspirator, with will cut and organize by described conduit and at least the part by described control handle move to container from described rotatable tool.

5. system according to claim 4:

Wherein, described control handle further comprises handle seat part and conduit base portion, and described handle seat is suitable for the described torsional axis that is positioned in the described conduit base revolving force is provided.

6. system according to claim 5:

Wherein, described handle seat and conduit base are suitable for being used for operating described control handle in the situation that need not tool using and link together.

7. system according to claim 1, wherein:

Described deflection piece comprises curved frames, described curved frames is included in the cross section that has the post intensity that reduces on the first radial side of described curved frames at least, and described curved frames is suitable for organizing cutting assembly in the situation that the first power is applied to described deflection control device at the direction upper deflecting of described the first radial side.

8. system according to claim 7:

Wherein, described curved frames is configured to limit the deflection that described tissue is removed assembly.

9. system according to claim 7:

Wherein, described curved frames is connected to conduit tube component.

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